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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81038

48 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

48 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 48

Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures

Z-0122-2019
Recall number
Z-0122-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
153

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 177820 177830 177890 177910 177920 244120 287770

Distribution pattern

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

device · product 2 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures

Z-0123-2019
Recall number
Z-0123-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
24

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 450640

Distribution pattern

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

device · product 3 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures

Z-0124-2019
Recall number
Z-0124-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
72

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 219750 244110 450750

Distribution pattern

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

device · product 4 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures

Z-0125-2019
Recall number
Z-0125-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
38

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 450770 450790

Distribution pattern

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

device · product 5 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures

Z-0126-2019
Recall number
Z-0126-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
51

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244100 584910 616470

Distribution pattern

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

device · product 6 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures

Z-0127-2019
Recall number
Z-0127-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
24

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 219760

Distribution pattern

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

device · product 7 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures

Z-0128-2019
Recall number
Z-0128-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
19

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 436160

Distribution pattern

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

device · product 8 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures

Z-0129-2019
Recall number
Z-0129-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
14

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 289130

Distribution pattern

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

device · product 9 of 48

Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures

Z-0130-2019
Recall number
Z-0130-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369120

Distribution pattern

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

device · product 10 of 48

Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures

Z-0131-2019
Recall number
Z-0131-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
153

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 129900 129910 178050 178060 178070 287720 287740

Distribution pattern

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

device · product 11 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures

Z-0132-2019
Recall number
Z-0132-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
27

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244090 288670

Distribution pattern

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

device · product 12 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures

Z-0133-2019
Recall number
Z-0133-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
12

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244170

Distribution pattern

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

device · product 13 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures

Z-0134-2019
Recall number
Z-0134-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244180

Distribution pattern

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

device · product 14 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures

Z-0135-2019
Recall number
Z-0135-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
51

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 289160 369250 369260

Distribution pattern

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

device · product 15 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures

Z-0136-2019
Recall number
Z-0136-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369280

Distribution pattern

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

device · product 16 of 48

Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures

Z-0137-2019
Recall number
Z-0137-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
18

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 436200

Distribution pattern

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

device · product 17 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures

Z-0138-2019
Recall number
Z-0138-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
34

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244220 558020

Distribution pattern

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

device · product 18 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures

Z-0139-2019
Recall number
Z-0139-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
24

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 343500

Distribution pattern

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

device · product 19 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures

Z-0140-2019
Recall number
Z-0140-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
22

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369340

Distribution pattern

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

device · product 20 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures

Z-0141-2019
Recall number
Z-0141-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
27

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 616680 616780

Distribution pattern

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

device · product 21 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures

Z-0142-2019
Recall number
Z-0142-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
9

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 136750

Distribution pattern

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

device · product 22 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures

Z-0143-2019
Recall number
Z-0143-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 584890

Distribution pattern

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

device · product 23 of 48

Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures

Z-0144-2019
Recall number
Z-0144-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
25

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 678960 678970

Distribution pattern

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

device · product 24 of 48

Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures

Z-0145-2019
Recall number
Z-0145-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
16

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 679000

Distribution pattern

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

device · product 25 of 48

Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures

Z-0146-2019
Recall number
Z-0146-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
78

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 201230 201240 500030 679050

Distribution pattern

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

device · product 26 of 48

Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures

Z-0147-2019
Recall number
Z-0147-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
14

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers:558060

Distribution pattern

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

device · product 27 of 48

Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures

Z-0148-2019
Recall number
Z-0148-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
29

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 584790 584810

Distribution pattern

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

device · product 28 of 48

Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures

Z-0149-2019
Recall number
Z-0149-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
30

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 584760 584770

Distribution pattern

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

device · product 29 of 48

Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures

Z-0150-2019
Recall number
Z-0150-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
33

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244270 679300

Distribution pattern

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

device · product 30 of 48

Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures

Z-0151-2019
Recall number
Z-0151-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
15

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 679160

Distribution pattern

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

device · product 31 of 48

Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures

Z-0152-2019
Recall number
Z-0152-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
60

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244280 558120 558130

Distribution pattern

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

device · product 32 of 48

Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures

Z-0153-2019
Recall number
Z-0153-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
68

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 244290 343530 343550

Distribution pattern

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

device · product 33 of 48

Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures

Z-0154-2019
Recall number
Z-0154-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
16

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 679240

Distribution pattern

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

device · product 34 of 48

Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures

Z-0155-2019
Recall number
Z-0155-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
31

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369380 436290

Distribution pattern

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

device · product 35 of 48

Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures

Z-0156-2019
Recall number
Z-0156-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
32

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369400 369410

Distribution pattern

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

device · product 36 of 48

Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

Z-0157-2019
Recall number
Z-0157-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
22

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 201440

Distribution pattern

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

device · product 37 of 48

Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures

Z-0158-2019
Recall number
Z-0158-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
85

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 136520 244300 244320 436430

Distribution pattern

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

device · product 38 of 48

Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures

Z-0159-2019
Recall number
Z-0159-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
39

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 616240 616250

Distribution pattern

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

device · product 39 of 48

Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures

Z-0160-2019
Recall number
Z-0160-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
24

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 369640

Distribution pattern

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

device · product 40 of 48

Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures

Z-0161-2019
Recall number
Z-0161-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
44

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 343590 343610

Distribution pattern

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

device · product 41 of 48

Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures

Z-0162-2019
Recall number
Z-0162-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 343630

Distribution pattern

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

device · product 42 of 48

Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures

Z-0163-2019
Recall number
Z-0163-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
50

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 436470 616630 616640

Distribution pattern

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

device · product 43 of 48

Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures

Z-0164-2019
Recall number
Z-0164-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
19

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 616460

Distribution pattern

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

device · product 44 of 48

Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures

Z-0165-2019
Recall number
Z-0165-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
14

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 289190

Distribution pattern

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

device · product 45 of 48

Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures

Z-0166-2019
Recall number
Z-0166-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
41

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 287810 343660

Distribution pattern

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

device · product 46 of 48

Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures

Z-0167-2019
Recall number
Z-0167-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
16

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 500220

Distribution pattern

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

device · product 47 of 48

Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures

Z-0168-2019
Recall number
Z-0168-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
10

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 436650

Distribution pattern

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

device · product 48 of 48

Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures

Z-0169-2019
Recall number
Z-0169-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging was already open

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Code information

Lot Numbers: 694950

Distribution pattern

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