Aesculap Safil Suture Recall Due to Needle Detachment Risk
Aesculap is recalling 180 units of Safil QUI + UNDY 5/0 sutures because the needle may detach from the thread during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the needle may detach during surgery, requiring the wound to be sutured a second time, but no injuries or illnesses have been reported.
Plain-English summary
Aesculap Implant Systems LLC is recalling 180 units of Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture (Lot # 115441, Product Code C1046619). The recall was initiated because there is a potential for the needle to detach from the suture thread during surgery.
The affected products were distributed in Arizona. If the needle becomes detached during a procedure, the defective suture will need to be replaced, causing the wound to be sutured a second time.
Healthcare facilities should stop using the affected sutures and contact Aesculap Implant Systems LLC for further instructions.
The recalled product
- Product
- Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 115441 Product Code C1046619
Distribution
Distributed in 1 state:
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