—#163060

Product

Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

FDA product code: MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K952535
Affected lot / code info: Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 130 & 120 Forbes Blvd, Mansfield, Massachusetts 02048

Distribution

Distribution pattern: Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.

Timeline

Recall initiated: 2017-12-11
Terminated: 2020-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.