FDA Device recall Z-1756-2015
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM
- FDA Device
- Class III
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class III recall of MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM 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-1756-2015 |
| 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
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
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: 141314; 141316; 141318; 141320; Use-by 2025-03-13; Lot Numbers: 035650; 035690; 065500; 066850; 066900; 0…Part Numbers: 141314; 141316; 141318; 141320; Use-by 2025-03-13; Lot Numbers: 035650; 035690; 065500; 066850; 066900; 066910; 066930; 066940; 066950; 066960; 066970; 066990; 067010; 104580; 104590; 104600; 104620; 104630; 104640; 104650; 104660; 125820; 125830; 125840; 129180; 183220; 183230; 183240; 183250; 183260; 183270; 183280; 183290; 183300; 183310; 183320; 257770; 257780; 257790; 257810; 257850; 257860; 257870; 257880; 299730; 299750; 299760; 299780; 299800; 299810; 299820; 842220; 951620; 954160; 997470; 023580; 077970; 125850; 251680; 335490; 997510; 997520; 997530; 997540; 078000; 078020; 104230; 125860; 251710; 335510; 997550; 997560; 997570; 078030; 104240; 114930; 333940; 529710; 997590 |
|---|
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-1756-2015%22
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