Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Company
- Smith & Nephew, Inc.
- Recall Initiated
- December 11, 2017
- Terminated
- September 21, 2020
- Recall Number
- Z-1536-2018
- Quantity
- 22
- Firm Location
- Mansfield, MA
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
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Lot / Code Info
Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
Root Cause
Employee error
Action Taken
On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at FieldActions@smith-nephew.com