Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture Recalled by Aesculap Implant Systems LLC Due to There is a potential for the needle to...

Date: August 1, 2016
Company: Aesculap Implant Systems LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.

Affected Products

Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

Quantity: 180 units

Why Was This 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.

Where Was This Sold?

Distributed in Arizona

About Aesculap Implant Systems LLC

Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report