Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Reported: November 2, 2016 Initiated: August 1, 2016 #Z-0316-2017
Product Description
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.
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 180 units
- Distribution
- Distributed in Arizona
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture. Recalled by Aesculap Implant Systems LLC. Units affected: 180 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2016. Severity: Moderate. Recall number: Z-0316-2017.
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