FDA Medical Device Recalls (openFDA)
Teleflex Medical: Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
- Recall number
- Z-0759-2017
- Recalling firm
- Teleflex Medical
- Product
- Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
- Status
- Terminated
- Initiated
- 2016-11-16
- Posted
- not on file
- Terminated
- 2017-12-13
- Reason
- The devices wings may become partially detached from the EFx Shield during use.
- Root cause
- Other
- Action
- Consignees were notified via letter on 11/16/2016.
- Quantity
- 2265 units
- Distribution
- Domestic; US Nationwide; International: Belgium, Canada.
- Lot, serial or model codes
- Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HCF
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- 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