Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
This recall has been terminated (originally issued November 16, 2016).
- Company
- Teleflex Medical
- Recall Initiated
- November 16, 2016
- Terminated
- December 13, 2017
- Recall Number
- Z-0759-2017
- Quantity
- 2265 units
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The devices wings may become partially detached from the EFx Shield during use.
Distribution
Domestic; US Nationwide; International: Belgium, Canada.
Lot / Code Info
Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
Root Cause
Other
Action Taken
Consignees were notified via letter on 11/16/2016.
More recalls by Teleflex Medical
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Jan 7, 2019