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.
This recall has been terminated (originally issued May 7, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- May 7, 2014
- Terminated
- August 14, 2017
- Recall Number
- Z-1560-2014
- Quantity
- 32,271 ea.
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
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.
Lot / Code Info
Product Code X-4981M4 - Lot 02J0800451
Root Cause
Employee error
Action Taken
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.