Persona Cemented Tibial Broach Inserter/Extractor — Class II medical device recall Z-0853-2015
Terminated recall by Zimmer, Inc., reported 2014-12-31, distributed in AL, CA, CO, FL, IL, MI, MN, NC…. The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the ma
| Recall number | Z-0853-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-05-13 |
| Distributed | AL, CA, CO, FL, IL, MI, MN, NC, NJ, OH, OR, PA |
| Countries outside the US | AE, AU, DE, IN, IT |
| Quantity | 83 units |
| Lot numbers | 62072307, 62072565, 62085420, 62192754 |
| Model numbers | 42-5399-023-00, 62072307, 62072565, 62085420, 62192754 |
Product
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
Reason for recall
The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi
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-0853-2015. 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.