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U.S. Department of Health and Human Services

Class 2 Device Recall Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture

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 Class 2 Recall
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture
see related information
Date Posted May 07, 2014
Recall Status1 Open
Recall Number Z-1560-2014
Recall Event ID 67711
Premarket Notification
510(K) Number
K930738 
Product Classification Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile - Product Code GAQ
Product Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Code Information Product Code X-4981M4 - Lot 02J0800451
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham, North Carolina 27703-9000
For Additional Information Contact Michael 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
OTHER/UNDETERMINED: Under Investigation by the firm
Action Urgent 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 Commerce 32,271 ea.
Distribution Worldwide 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GAQ and Original Applicant = DEKNATEL, INC.
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