Device product
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Z-0759-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 75693
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2265 units
- Official record key
device-enforcement:Z-0759-2017
Official wording
Reason: The devices wings may become partially detached from the EFx Shield during use.
Code information: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
Distribution pattern: Domestic; US Nationwide; International: Belgium, Canada.
Derived failure modes
-
Unknown
The devices wings may become partially detached from the EFx Shield during use.