Device product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Z-1536-2018
Product summary
- Event
- Event 79700
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22
- Official record key
device-enforcement:Z-1536-2018
Official wording
Reason: Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
Code information: Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
Distribution pattern: Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Derived failure modes
-
Sterility assurance
sterile barrier breach