Zimmer PERSONA Tibial Articular Surface Inserter — Class II medical device recall Z-1042-2015
Terminated recall by Zimmer, Inc., reported 2015-02-11, distributed nationwide. Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size
| Recall number | Z-1042-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-11-25 |
| Classified | 2015-02-03 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, DO, JP, KR, SG |
| Quantity | 1,091 |
| Reason classes | device malfunction |
| Lot numbers | 56572679, 56572918, 56572975, 56572978, 56572981, 56572982, 56573071, 56573115, 56573116, 56573154, 56573170, 56573378, 56573379, 56574123, 56574124, 56574223, 56574291, 56574292, 56574316, 56574317, 56574318, 56574538, 56574540, 56574618, 56574619, 56574620, 56574629, 56574630, 56574631, 56575018, 56575056, 56575057, 56575058, 56575059, 56575060, 56575061, 56575062, 56575065, 56575080 |
| Model numbers | 42-5299-001-00 |
Product
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Reason for recall
Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
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.