—#126184

Product

Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be 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: GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K021019
Affected lot / code info: Product Code: X-4981M4, Lot number: 02J0800451

Why it was recalled

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Root cause (FDA determination)

Employee error

Action the firm took

Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-03-26
Terminated: 2017-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126184. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.