FDA-Device2014-04-02Class II

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 u

Teleflex Medical
Hazard

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

Sold states
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Affected count
Total 32,271 ea.
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2014

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