FDA event 80755 · Recall Observatory

device · product 1 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280

Z-3046-2018

Recall number: Z-3046-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331370 500240

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 2 of 129

Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

Z-3047-2018

Recall number: Z-3047-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 3 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300

Z-3048-2018

Recall number: Z-3048-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017130 052890 052910

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 4 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320

Z-3049-2018

Recall number: Z-3049-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

789980

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 5 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360

Z-3050-2018

Recall number: Z-3050-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

050830 052950 417420

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 6 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380

Z-3051-2018

Recall number: Z-3051-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

814250

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 7 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm, Item Number: 814309420

Z-3052-2018

Recall number: Z-3052-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

151830 886880

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 8 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440

Z-3053-2018

Recall number: Z-3053-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

814090 899810

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 9 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460

Z-3054-2018

Recall number: Z-3054-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

097120 767700

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 10 of 129

Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

Z-3055-2018

Recall number: Z-3055-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 11 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280

Z-3056-2018

Recall number: Z-3056-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

500770 790170

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 12 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300

Z-3057-2018

Recall number: Z-3057-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

132800

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 13 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320

Z-3058-2018

Recall number: Z-3058-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

900040

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 14 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm, Item Number: 814311340

Z-3059-2018

Recall number: Z-3059-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

152960 331460 456050 944450

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 15 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 360 mm, Item Number: 814311360

Z-3060-2018

Recall number: Z-3060-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

132900 150870 331470 773070 688290

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 16 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380

Z-3061-2018

Recall number: Z-3061-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

132920 188120 331480 688320 814070

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 17 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400

Z-3062-2018

Recall number: Z-3062-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

097130 245980 417450 519300 854260 645620 645650

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 18 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420

Z-3063-2018

Recall number: Z-3063-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

060900 331520 417460 645670 688350 017270

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 19 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440

Z-3064-2018

Recall number: Z-3064-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

050850 155250 500840 541270 559240

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 20 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm, Item Number: 814311460

Z-3065-2018

Recall number: Z-3065-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017290 063450 155220 500860

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 21 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180

Z-3066-2018

Recall number: Z-3066-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

060870 063550 063560 063570 114480 645700 900100 900250 944470 500880

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 22 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260

Z-3067-2018

Recall number: Z-3067-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

053670 813260

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 23 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm, Item Number: 814313280

Z-3068-2018

Recall number: Z-3068-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

053750 813300

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 24 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300

Z-3069-2018

Recall number: Z-3069-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

645720

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 25 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320

Z-3070-2018

Recall number: Z-3070-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331530 971020

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 26 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340

Z-3071-2018

Recall number: Z-3071-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

133040 188240 645750

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 27 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360

Z-3072-2018

Recall number: Z-3072-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

050870 501210 645770

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 28 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm, Item Number: 814313380

Z-3073-2018

Recall number: Z-3073-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

482620 501270 813390

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 29 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400

Z-3074-2018

Recall number: Z-3074-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

501350

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 30 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420

Z-3075-2018

Recall number: Z-3075-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017300 097020 559190

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 31 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm, Item Number: 814313440

Z-3076-2018

Recall number: Z-3076-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155200 502270 051080

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 32 of 129

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460

Z-3077-2018

Recall number: Z-3077-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

083760 017310

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 33 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 260 mm, Item Number: 814409260

Z-3078-2018

Recall number: Z-3078-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

971030

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 34 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 280 mm, Item Number: 814409280

Z-3079-2018

Recall number: Z-3079-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

707700

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 35 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300

Z-3080-2018

Recall number: Z-3080-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

133160 790790

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 36 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320

Z-3081-2018

Recall number: Z-3081-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

114560 133170

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 37 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 340 mm, Item Number: 814409340

Z-3082-2018

Recall number: Z-3082-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

212940 503520 565820 645800 971050

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 38 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360

Z-3083-2018

Recall number: Z-3083-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

097140 133190 144070

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 39 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 380 mm, Item Number: 814409380

Z-3084-2018

Recall number: Z-3084-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

053790 155180 762720 790780 813530

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 40 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400

Z-3085-2018

Recall number: Z-3085-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

051130 053810 133200 153200 813940 097150 767720

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 41 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420

Z-3086-2018

Recall number: Z-3086-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

503570 790820

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 42 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440

Z-3087-2018

Recall number: Z-3087-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

503610 900270

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 43 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460

Z-3088-2018

Recall number: Z-3088-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

097160 133230

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 44 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 260 mm, Item Number: 814411260

Z-3089-2018

Recall number: Z-3089-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

503640

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 45 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320

Z-3090-2018

Recall number: Z-3090-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155130 813600

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 46 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340

Z-3091-2018

Recall number: Z-3091-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

530180 585810

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 47 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360

Z-3092-2018

Recall number: Z-3092-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

503700 646540 707750 519470

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 48 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 380 mm, Item Number: 814411380

Z-3093-2018

Recall number: Z-3093-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

053940 813860 886990

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 49 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400

Z-3094-2018

Recall number: Z-3094-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

053980 053990 646590 768010 530100 646600

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 50 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420

Z-3095-2018

Recall number: Z-3095-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155120 245960 472890 813680 813860

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 51 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 440 mm, Item Number: 814411440

Z-3096-2018

Recall number: Z-3096-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

151870 155110 646620 960600 646630 646640

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 52 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460

Z-3097-2018

Recall number: Z-3097-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054000 097060 285050 287410

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 53 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260

Z-3098-2018

Recall number: Z-3098-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

814090

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 54 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280

Z-3099-2018

Recall number: Z-3099-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

559130

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 55 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300

Z-3100-2018

Recall number: Z-3100-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331610

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 56 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320

Z-3101-2018

Recall number: Z-3101-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

245830 331620

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 57 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340

Z-3102-2018

Recall number: Z-3102-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

482730 155980 156040

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 58 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 360 mm, Item Number: 814413360

Z-3103-2018

Recall number: Z-3103-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054030 054040 312200 312210

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 59 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380

Z-3104-2018

Recall number: Z-3104-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

417480 646660

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 60 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 400 mm, Item Number: 814413400

Z-3105-2018

Recall number: Z-3105-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054100 646680

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 61 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420

Z-3106-2018

Recall number: Z-3106-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155080 156070 156150 482640 762730

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 62 of 129

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 460 mm, Item Number: 814413460

Z-3107-2018

Recall number: Z-3107-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155070

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 63 of 129

Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180

Z-3108-2018

Recall number: Z-3108-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054130 085710 144520 150790 156740 156750 219790 245740 245820 287290 287400 456140 482650 707780 900280 944590 944630 944640 970640 609640 609650

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 64 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260

Z-3109-2018

Recall number: Z-3109-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

813650

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 65 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 280 mm, Item Number: 814509280

Z-3110-2018

Recall number: Z-3110-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

768020

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 66 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300

Z-3111-2018

Recall number: Z-3111-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

212980 128150 971560

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 67 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 320 mm, Item Number: 814509320

Z-3112-2018

Recall number: Z-3112-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

530190 887000 971580

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 68 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 340 mm, Item Number: 814509340

Z-3113-2018

Recall number: Z-3113-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

503940 646730

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 69 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360

Z-3114-2018

Recall number: Z-3114-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

813470 646750

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 70 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380

Z-3115-2018

Recall number: Z-3115-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

628920 646790 773060

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 71 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400

Z-3116-2018

Recall number: Z-3116-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

646830 900740

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 72 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420

Z-3117-2018

Recall number: Z-3117-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

153010 159190 707830 503950 503960

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 73 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440

Z-3118-2018

Recall number: Z-3118-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054150 054170 130740 130750 188310 519480 472970 503970

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 74 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 460 mm, Item Number: 814509460

Z-3119-2018

Recall number: Z-3119-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

254720 017420 960610

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 75 of 129

Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180

Z-3120-2018

Recall number: Z-3120-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 76 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260

Z-3121-2018

Recall number: Z-3121-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

791640 813460

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 77 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280

Z-3122-2018

Recall number: Z-3122-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

155000 483480 646910 646930 646950 353610

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 78 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 300 mm, Item Number: 814511300

Z-3123-2018

Recall number: Z-3123-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

558960

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 79 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 320 mm, Item Number: 814511320

Z-3124-2018

Recall number: Z-3124-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331650

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 80 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340

Z-3125-2018

Recall number: Z-3125-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054180 483490 519590 558900 558910 586640 371200

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 81 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360

Z-3126-2018

Recall number: Z-3126-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 82 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380

Z-3127-2018

Recall number: Z-3127-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054200 054210 054220 519620 519630 813210

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 83 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400

Z-3128-2018

Recall number: Z-3128-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

054240 054250 154980 472860 773390 798600 798610 017490 245530

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 84 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm, Item Number: 814511420

Z-3129-2018

Recall number: Z-3129-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154960 558870 558880 628930 707860 171860 171870

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 85 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm, Item Number: 814511440

Z-3130-2018

Recall number: Z-3130-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

213000 558850

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 86 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 460 mm, Item Number: 814511460

Z-3131-2018

Recall number: Z-3131-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

157130 558840 710910

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 87 of 129

Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180

Z-3132-2018

Recall number: Z-3132-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

063590 063600 220020 245510 290720 371210 482750 482760 482770 523410 097180 188350 188370 290690 970510 970530 970580

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 88 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260

Z-3133-2018

Recall number: Z-3133-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

901420

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 89 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280

Z-3134-2018

Recall number: Z-3134-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

213010 707970 944730

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 90 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300

Z-3135-2018

Recall number: Z-3135-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

944850

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 91 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340

Z-3136-2018

Recall number: Z-3136-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017700

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 92 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380

Z-3137-2018

Recall number: Z-3137-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

587670 707980 711060

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 93 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400

Z-3138-2018

Recall number: Z-3138-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

152980 482780 530160 798520 798530 798540 773050

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 94 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm, Item Number: 814513420

Z-3139-2018

Recall number: Z-3139-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

060800 060820 397280 397290 397300 812970 901490 418360

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 95 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440

Z-3140-2018

Recall number: Z-3140-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154920 711080 017710

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 96 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460

Z-3141-2018

Recall number: Z-3141-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

558790 711090 901520

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 97 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm, Item Number: 814515320

Z-3142-2018

Recall number: Z-3142-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154900 818440

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 98 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360

Z-3143-2018

Recall number: Z-3143-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154890 814740

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 99 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400

Z-3144-2018

Recall number: Z-3144-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

364250

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 100 of 129

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440

Z-3145-2018

Recall number: Z-3145-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154880

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 101 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260

Z-3146-2018

Recall number: Z-3146-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

157170

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 102 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280

Z-3147-2018

Recall number: Z-3147-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

107860 558680 791850 091560

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 103 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320

Z-3148-2018

Recall number: Z-3148-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

055260 154870 721080

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 104 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360

Z-3149-2018

Recall number: Z-3149-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

287140

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 105 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 400 mm, Item Number: 814609400

Z-3150-2018

Recall number: Z-3150-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

055360 055510 157290 917700 972060 812750 812920 812930

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 106 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420

Z-3151-2018

Recall number: Z-3151-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

762840

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 107 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 460 mm, Item Number: 814609460

Z-3152-2018

Recall number: Z-3152-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

055580 154820 154830 245470

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 108 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260

Z-3153-2018

Recall number: Z-3153-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

091610 558640 629150

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 109 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm, Item Number: 814611280

Z-3154-2018

Recall number: Z-3154-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

711150 711170

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 110 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320

Z-3155-2018

Recall number: Z-3155-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331940 558590 900100

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 111 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm, Item Number: 814611340

Z-3156-2018

Recall number: Z-3156-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154800 154810 155350 629170 157430 587790 944920

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 112 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360

Z-3157-2018

Recall number: Z-3157-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 113 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380

Z-3158-2018

Recall number: Z-3158-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

152900 154610 901540 901550 901560 901570 901580 901590 901600 565970 609690

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 114 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400

Z-3159-2018

Recall number: Z-3159-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

060780 154560 482790 530170 759190 797000 797020 812460 812540 759180

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 115 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420

Z-3160-2018

Recall number: Z-3160-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154540 155340 712170 791890 712240 812340

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 116 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440

Z-3161-2018

Recall number: Z-3161-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

558490 759400

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 117 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460

Z-3162-2018

Recall number: Z-3162-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

171830 712290

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 118 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 260 mm, Item Number: 814613260

Z-3163-2018

Recall number: Z-3163-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

171820 972190

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 119 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280

Z-3164-2018

Recall number: Z-3164-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

688510 763000

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 120 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300

Z-3165-2018

Recall number: Z-3165-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

818430 960660

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 121 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320

Z-3166-2018

Recall number: Z-3166-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

245390 287180

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 122 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340

Z-3167-2018

Recall number: Z-3167-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

331960

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 123 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360

Z-3168-2018

Recall number: Z-3168-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

816070 091850

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 124 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380

Z-3169-2018

Recall number: Z-3169-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

712320 145040

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 125 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400

Z-3170-2018

Recall number: Z-3170-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

055730 060770 154510 558410 712370 543380

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 126 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420

Z-3171-2018

Recall number: Z-3171-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154480 482820

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 127 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440

Z-3172-2018

Recall number: Z-3172-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

157490 482830

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 128 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460

Z-3173-2018

Recall number: Z-3173-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

055760 154460 503740 558390 712400

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

device · product 129 of 129

Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360

Z-3174-2018

Recall number: Z-3174-2018
Initiated: July 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 5947 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

Code information

154450 791930

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

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