FDA event 82642 · Recall Observatory

device · product 1 of 76

Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106

Z-1413-2019

Recall number: Z-1413-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 2 of 76

Drill Sys2.7, 2x103mm, AO, Item Number 502015107

Z-1414-2019

Recall number: Z-1414-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 3 of 76

Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114

Z-1415-2019

Recall number: Z-1415-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 4 of 76

Drill, 15mm stop, 1x76mm, AO , Item Number 502015115

Z-1416-2019

Recall number: Z-1416-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 5 of 76

Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120

Z-1417-2019

Recall number: Z-1417-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 6 of 76

Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124

Z-1418-2019

Recall number: Z-1418-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 7 of 76

Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130

Z-1419-2019

Recall number: Z-1419-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 8 of 76

Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131

Z-1420-2019

Recall number: Z-1420-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 9 of 76

Drill, 2.5x94mm, Stryker, Item Number 502015136

Z-1421-2019

Recall number: Z-1421-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 10 of 76

Drill, 2.5x87mm, AO, Item Number 502015137

Z-1422-2019

Recall number: Z-1422-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 11 of 76

Drill, 2.5x135mm, AO, Item Number 502015142

Z-1423-2019

Recall number: Z-1423-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 12 of 76

Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145

Z-1424-2019

Recall number: Z-1424-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 13 of 76

Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146

Z-1425-2019

Recall number: Z-1425-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 14 of 76

Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206

Z-1426-2019

Recall number: Z-1426-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 15 of 76

Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207

Z-1427-2019

Recall number: Z-1427-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 16 of 76

Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208

Z-1428-2019

Recall number: Z-1428-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 17 of 76

Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211

Z-1429-2019

Recall number: Z-1429-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 18 of 76

Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212

Z-1430-2019

Recall number: Z-1430-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 19 of 76

Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213

Z-1431-2019

Recall number: Z-1431-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 20 of 76

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216

Z-1432-2019

Recall number: Z-1432-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 21 of 76

Drill, 2.7x125mm, AO, Item Number 502015217

Z-1433-2019

Recall number: Z-1433-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 22 of 76

Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218

Z-1434-2019

Recall number: Z-1434-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 23 of 76

Drill, cannulated, 4x120mm, AO, Item Number 502015402

Z-1435-2019

Recall number: Z-1435-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 24 of 76

Drill, cannulated, 4x150mm, AO, Item Number 502015403

Z-1436-2019

Recall number: Z-1436-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 25 of 76

Drill, cannulated, 2x95mm, round shaft, Item Number 502015619

Z-1437-2019

Recall number: Z-1437-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 26 of 76

Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620

Z-1438-2019

Recall number: Z-1438-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 27 of 76

Drill, cannulated, 2.5x95mm, AO, Item Number 502015621

Z-1439-2019

Recall number: Z-1439-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 28 of 76

Drill, cannulated, 2x95mm, AO, Item Number 502015623

Z-1440-2019

Recall number: Z-1440-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 29 of 76

Drill, cannulated, 2.8x120mm, AO, Item Number 502015628

Z-1441-2019

Recall number: Z-1441-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 30 of 76

Drill, cannulated, 2.8x150mm, AO, Item Number 502015629

Z-1442-2019

Recall number: Z-1442-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 31 of 76

Drill, cannulated, 3x90mm, round shaft, Item Number 502015630

Z-1443-2019

Recall number: Z-1443-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 32 of 76

Drill, cannulated, 3x90mm, AO, Item Number 502015631

Z-1444-2019

Recall number: Z-1444-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 33 of 76

V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634

Z-1445-2019

Recall number: Z-1445-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 34 of 76

Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635

Z-1446-2019

Recall number: Z-1446-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 35 of 76

V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636

Z-1447-2019

Recall number: Z-1447-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 36 of 76

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637

Z-1448-2019

Recall number: Z-1448-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 37 of 76

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638

Z-1449-2019

Recall number: Z-1449-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 38 of 76

Drill, cannulated, 4x90mm, round shaft, Item Number 502015640

Z-1450-2019

Recall number: Z-1450-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 39 of 76

Drill, 3.2x145mm, AO, Item Number 502015650

Z-1451-2019

Recall number: Z-1451-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 40 of 76

Drill, contra-angle, 1.5x85mm, Item Number 502015706

Z-1452-2019

Recall number: Z-1452-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 41 of 76

CBS 7.5 tap, cannulated, AO, Item Number 503002041

Z-1453-2019

Recall number: Z-1453-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 42 of 76

MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177

Z-1454-2019

Recall number: Z-1454-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 43 of 76

CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

Z-1455-2019

Recall number: Z-1455-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 44 of 76

CBS high, countersink, cannulated, round-shaft, Item Number 503004342

Z-1456-2019

Recall number: Z-1456-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 45 of 76

CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351

Z-1457-2019

Recall number: Z-1457-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 46 of 76

CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

Z-1458-2019

Recall number: Z-1458-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 47 of 76

CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

Z-1459-2019

Recall number: Z-1459-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 48 of 76

CBS micro, countersink, cannulated, AO, Item Number 503004541

Z-1460-2019

Recall number: Z-1460-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 49 of 76

CBS high, countersink, cannulated, AO, Item Number 503004542

Z-1461-2019

Recall number: Z-1461-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 50 of 76

V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110

Z-1462-2019

Recall number: Z-1462-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 51 of 76

V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111

Z-1463-2019

Recall number: Z-1463-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 52 of 76

V-TEK", micro-countersink, round shaft, Item Number 28.66.112

Z-1464-2019

Recall number: Z-1464-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 53 of 76

V-TEK", Micro-countersink, AO, Item Number 28.66.113

Z-1465-2019

Recall number: Z-1465-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 54 of 76

V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111

Z-1466-2019

Recall number: Z-1466-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 55 of 76

V-TEK", Micro-countersink, AO , Item Number ST28.66.113

Z-1467-2019

Recall number: Z-1467-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 56 of 76

Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206

Z-1468-2019

Recall number: Z-1468-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 57 of 76

Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207

Z-1469-2019

Recall number: Z-1469-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 58 of 76

Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208

Z-1470-2019

Recall number: Z-1470-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 59 of 76

Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212

Z-1471-2019

Recall number: Z-1471-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 60 of 76

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216

Z-1472-2019

Recall number: Z-1472-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 61 of 76

Drill, 2.7x125mm, AO , Item Number ST502015217

Z-1473-2019

Recall number: Z-1473-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 62 of 76

Drill, cannulated, 4x120mm, AO, Item Number ST502015402

Z-1474-2019

Recall number: Z-1474-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 63 of 76

Drill, cannulated, 4x150mm, AO, Item Number ST502015403

Z-1475-2019

Recall number: Z-1475-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 64 of 76

Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619

Z-1476-2019

Recall number: Z-1476-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 65 of 76

Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620

Z-1477-2019

Recall number: Z-1477-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 66 of 76

Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621

Z-1478-2019

Recall number: Z-1478-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 67 of 76

Drill, cannulated, 2x95mm, AO, Item Number ST502015623

Z-1479-2019

Recall number: Z-1479-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 68 of 76

Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628

Z-1480-2019

Recall number: Z-1480-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 69 of 76

Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630

Z-1481-2019

Recall number: Z-1481-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 70 of 76

Drill, cannulated, 3x90mm, AO, Item Number ST502015631

Z-1482-2019

Recall number: Z-1482-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 71 of 76

Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635

Z-1483-2019

Recall number: Z-1483-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 72 of 76

Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640

Z-1484-2019

Recall number: Z-1484-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 73 of 76

Drill, 3.2x145mm, AO, Item Number ST502015650

Z-1485-2019

Recall number: Z-1485-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 74 of 76

Drill, contra-angle, 1.5x85mm, Item Number ST502015706

Z-1486-2019

Recall number: Z-1486-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 75 of 76

CBS micro, countersink, cannulated, AO, Item Number ST503004541

Z-1487-2019

Recall number: Z-1487-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

device · product 76 of 76

CBS high, countersink, cannulated, AO, Item Number ST503004542

Z-1488-2019

Recall number: Z-1488-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Zimmer GmbH
Quantity: N/A

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

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information

All items marked with "Normed" are affected

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Event summary

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Every recalled product in this event

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