Z-1536-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- December 11, 2017
- Termination Date
- September 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
Product Description
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Reason for Recall
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.
Distribution Pattern
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Code Information
Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355