Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
FDA Recall Z-1536-2018 · Posted None
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Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMAI
Date Initiated2017-12-11
Date Terminated2020-09-21
Product Quantity22
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.
Firm Action
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 [email protected]
Root Cause
Employee error
Distribution Pattern
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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