Recall Z-1295-2014 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Teleflex Medical
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 m
| Date | Mar 26, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | The products are being recalled because they did not meet minimum needle attachment strength requirements. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | Total 32,271 ea. |
| Distribution | Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE Genzyme Corp., Jun 18, 2002 |