—#126533

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.

FDA product code: GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K930738
Affected lot / code info: Product Code X-4981M4 - Lot 02J0800451

Why it was recalled

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-05-07
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126533. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.