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U.S. Department of Health and Human Services

Class 2 Device Recall WHIPKNOT Soft Tissue Cinch

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  Class 2 Device Recall WHIPKNOT Soft Tissue Cinch see related information
Date Initiated by Firm December 11, 2017
Create Date April 26, 2018
Recall Status1 Terminated 3 on September 21, 2020
Recall Number Z-1536-2018
Recall Event ID 79700
510(K)Number K952535  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Code Information Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
Manufacturer 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 2		 Employee error
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 FieldActions@smith-nephew.com
Quantity in Commerce 22
Distribution Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = ACUFEX MICROSURGICAL, INC.
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