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

• Date Initiated by Firm: March 11, 2014
• Date Posted: May 07, 2014
• Recall Status: Terminated on August 14, 2017
• Recall Number: Z-1560-2014
• Recall Event ID: 67711
• 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 NC 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: Employee error
• 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 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 = GAQ