Gentle Thread PLGA Round Head Interference Screw — Class II medical device recall Z-3176-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-09-26, distributed in IN, TN. The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
| Recall number | Z-3176-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-07-20 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-06-04 |
| Distributed | IN, TN |
| Countries outside the US | AU, CL, NL |
| Quantity | 52 |
| UPC / GTIN / UDI-DI | 00880304008526 |
| Lot numbers | 611330 |
| Model numbers | 905612 |
Product
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Reason for recall
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
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-3176-2018. 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.