FDA Recall
Terminated
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Recall: Z-0759-2017
·
Initiated November 16, 2016
Recall
- Recall Number
- Z-0759-2017
- Event Number
- 75693
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- HCF
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 16, 2016
- Terminated
- December 13, 2017
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186
Description
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Reason
The devices wings may become partially detached from the EFx Shield during use.
Action
Consignees were notified via letter on 11/16/2016.
Distribution
Domestic; US Nationwide; International: Belgium, Canada.
Quantity
2265 units