Gentle Threads — Class II medical device recall Z-1739-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-16, distributed nationwide. Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infect
| Recall number | Z-1739-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-03-28 |
| Classified | 2018-05-08 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CR, KR, MX, MY, NL, PY |
| Quantity | 107 |
| Reason classes | sterility |
| Lot numbers | 326980, 371540 |
| Model numbers | 905615 |
Product
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Reason for recall
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
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-1739-2018. 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.