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U.S. Department of Health and Human Services

Class 2 Device Recall Suture, Absorbable, Synthetic, Polyglycolic Acid

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 Class 2 Device Recall Suture, Absorbable, Synthetic, Polyglycolic Acidsee related information
Date Initiated by FirmMarch 11, 2014
Date PostedMay 07, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall NumberZ-1558-2014
Recall Event ID 67711
510(K)NumberK930738 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductFixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Code Information Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information ContactMichael T. Taggart
919-433-4940
Manufacturer Reason
for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
FDA Determined
Cause 2
Employee error
ActionUrgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Quantity in Commerce32,271 ea.
DistributionWorldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GAM
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