Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A… — Class II medical device recall Z-2068-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-05-17, distributed nationwide. pegs shearing post-operatively
| Recall number | Z-2068-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-05-10 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-10-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 8,154 |
| Model numbers | 141355, 141356, 141357, 141358 |
Product
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Reason for recall
pegs shearing post-operatively
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.