Zimmer Segmental System Proximal Femoral Component 38mm Offset — Class II medical device recall Z-1381-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-04-25, distributed nationwide. There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machin
| Recall number | Z-1381-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-03-29 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-12-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, KR, MY, NL, SG |
| Quantity | 1,145 distribution |
| Model numbers | 00-5850-030-38 |
Product
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Reason for recall
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
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-1381-2018. 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.