VERSYS 7 — Class II medical device recall Z-1028-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-21, distributed nationwide. The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished sur
| Recall number | Z-1028-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BO, BR, CA, CL, CN, CO, EC, IN, JP, KR, MX, MY, NI, NL, NZ, PA, SG, SV, TH, TW |
| Quantity | 13,227 in |
| Lot numbers | 62158840 |
| Model numbers | 00-7843-013-18 |
Product
VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
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-1028-2018. 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.