Safil QUI + UNDY 5/0 recall
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Why was Safil QUI + UNDY 5/0 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 115441 Product Code C1046619
- Product
- Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 180 units
- Distribution
- Distributed in Arizona
- Recall date
- November 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)