Safil QUI + UNDY 5/0 — Class II medical device recall Z-0316-2017
Terminated recall by Aesculap Implant Systems LLC, reported 2016-11-02, distributed in AZ. There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes det
| Recall number | Z-0316-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2016-08-01 |
| Classified | 2016-10-26 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-02-16 |
| Distributed | AZ |
| Quantity | 180 units |
| Reason classes | device malfunction |
| Lot numbers | 115441 |
Product
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Reason for recall
There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
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-0316-2017. 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.