FDA Device recall Z-1757-2015
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK
- FDA Device
- Class III
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class III recall of Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK by Biomet, citing biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1757-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Reason
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Identifiers
| code_info | Part Numbers: 163667; 163668; 163669; 163670; 163674; Use-by 2025-03-18; Lot Numbers: 331620; 331650; 453080; 453090; 4…Part Numbers: 163667; 163668; 163669; 163670; 163674; Use-by 2025-03-18; Lot Numbers: 331620; 331650; 453080; 453090; 453110; 453120; 489140; 453180; 471380; 471410; 044600; 332720; 375590; 375620; 375630; 375640; 375650; 465840; 466050; 470060; 471430; 471440; 471450; 375660; 375670; 375700; 453220 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1757-2015%22
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