Recall Z-1536-2018
Smith & Nephew, Inc. · initiated December 11, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Codes / lots: Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
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.
FDA-determined 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
Details
- Recall number
- Z-1536-2018
- Initiated
- December 11, 2017
- Terminated
- September 21, 2020
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Quantity
- 22
- Distribution
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
- Recalling firm
- Smith & Nephew, Inc., Mansfield, MA