Device 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.
Z-1295-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67733
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 32,271 ea.
- Official record key
device-enforcement:Z-1295-2014
Official wording
Reason: The products are being recalled because they did not meet minimum needle attachment strength requirements.
Code information: Product Code: X-4981M4, Lot number: 02J0800451
Distribution pattern: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Derived failure modes
-
Unknown
The products are being recalled because they did not meet minimum needle attachment strength requirements.