FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
- Recall number
- Z-0316-2017
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
- Status
- Terminated
- Initiated
- 2016-08-01
- Posted
- not on file
- Terminated
- 2018-02-16
- Reason
- 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.
- Root cause
- Process control
- Action
- An Urgent Medical Device Recall Notification Letter was mailed to customers on August 11, 2016 asking them to remove and return the affected product immediately.
- Quantity
- 180 units
- Distribution
- Distributed in Arizona
- Lot, serial or model codes
- Lot # 115441 Product Code C1046619
- 510(k) numbers
- ["K031286"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28