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.
This recall has been terminated (originally issued March 26, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- March 26, 2014
- Terminated
- August 15, 2017
- Recall Number
- Z-1295-2014
- Quantity
- Total 32,271 ea.
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Distribution
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Lot / Code Info
Product Code: X-4981M4, Lot number: 02J0800451
Root Cause
Employee error
Action Taken
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