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U.S. Department of Health and Human Services

Class 2 Device Recall Suture, Nonabsorbable, Synthetic, Polyamide

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  Class 2 Device Recall Suture, Nonabsorbable, Synthetic, Polyamide see related information
Date Initiated by Firm March 11, 2014
Date Posted March 26, 2014
Recall Status1 Terminated 3 on August 15, 2017
Recall Number Z-1291-2014
Recall Event ID 67733
510(K)Number K021019  
Product Classification Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
Product Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only,

Product Usage:
Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.
Code Information Product Code: 1154654, Lot number: 02K0801212
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 The products are being recalled because they did not meet minimum needle attachment strength requirements.
FDA Determined
Cause 2		 Employee error
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Quantity in Commerce Total 32,271 ea.
Distribution Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
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 = GAT and Original Applicant = GENZYME CORP.
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