Modular Head Component — Class II medical device recall Z-1538-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-09, distributed nationwide. Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocati
| Recall number | Z-1538-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-04-02 |
| Classified | 2018-04-27 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CR |
| Quantity | 18 |
| Lot numbers | 299340 |
| Model numbers | 11-363661 |
Product
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Reason for recall
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
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-1538-2018. 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.