FDA Device recall Z-1537-2018
Modular Head Component, Biomet Hip System
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Modular Head Component, Biomet Hip System by Zimmer Biomet, citing two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1537-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-02 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Reason
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Identifiers
| code_info | lot 276760 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1537-2018%22
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