CLASS II Device recall · Reported 2 Nov 2016 · FDA Enforcement Report

Safil QUI + UNDY 5/0 DSMP13 Suture recalled by Aesculap Implant Systems

Aesculap Implant Systems is recalling Safil QUI + UNDY 5/0 DSMP13 Suture, distributed in Arizona. The recall was initiated on 1 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 115441 Product Code C1046619

Quantity recalled180 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0316-2017
FDA event ID: 75142
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Aug 2016
FDA classified: 26 Oct 2016
Reported: 2 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

1 Aug 2016	Recall initiated by company
26 Oct 2016	Classified by FDA	+86 days
2 Nov 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Distributed in Arizona

Arizona

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # 115441 Product Code C1046619

Where was it sold?

Distributed in Arizona

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aesculap Implant Systems

All 61

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023Device	CLASS II	For intraventricular recalled by Aesculap Implant Systems	Aesculap Implant Systems	Device Malfunction	Nationwide
26 Jul 2023Device	CLASS II	Aesculap Surgical Needle, straight, 3 1/2", width recalled	Aesculap Implant Systems	Packaging Defects	Nationwide
17 May 2023Device	CLASS II	Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems	Aesculap Implant Systems	Other	Nationwide
3 May 2023Device	CLASS II	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled	Aesculap Implant Systems	Labeling Errors	Nationwide
7 Sep 2022Device	CLASS II	Aesculap Ennovate Set Screw Sterile-implants are used recalled	Aesculap Implant Systems	Packaging Defects	GA, TX

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide