Persona Cemented Tibial SZ PLT Size H Left — Class II medical device recall Z-1807-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-23, distributed nationwide. There is a potential for intermittent cracks in the raw material batch used to produce the affected products.
| Recall number | Z-1807-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2018-05-11 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2018-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, IN, JP, KR, MY, NL, SG |
| Quantity | 842 products |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00889024247574 |
| Lot numbers | 63531869, 63576035, 63649575, 63693589 |
| Model numbers | 42539908301 |
Product
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Reason for recall
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
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-1807-2018. 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.