The Persona Tibial Articular Surface Inserter is a sterilizable… — Class II medical device recall Z-0123-2015
Terminated recall by Zimmer, Inc., reported 2014-10-29, distributed nationwide. Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the
| Recall number | Z-0123-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-10-07 |
| Classified | 2014-10-23 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, KR, SG |
| Quantity | 618 units |
| Lot numbers | 56572679, 56572918, 56572975, 56572978, 56572981, 56572982, 56573071, 56573115, 56573116, 56573154, 56573170, 56573378, 56573379, 56574223, 56574291, 56574292, 56574316, 56574317, 56574318 |
| Model numbers | 42-5299-001-00, 56572679 |
Product
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
Reason for recall
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0123-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.