FDA Device recall Z-0316-2017
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture by Aesculap Implant Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0316-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-01 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesculap Implant Systems |
| Distribution | AZ |
Product
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Reason
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.
Identifiers
| code_info | Lot # 115441 Product Code C1046619 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0316-2017%22
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