Affixus Hip Fracture Nail — Class II medical device recall Z-0454-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-02-07, distributed nationwide. During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve
| Recall number | Z-0454-2018 |
|---|---|
| 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 | 2018-01-29 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL, PT |
| Quantity | 638 units |
| UPC / GTIN / UDI-DI | 00887868037979 |
| Lot numbers | 702050 |
| Model numbers | 814309260 |
Product
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
Reason for recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
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-0454-2018. 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.