Home / Recalls / Medical Devices
Teleflex Medical recalls Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or thread
Recalled April 2, 2014 · FDA recall Z-1295-2014 · Teleflex Medical
Hazard
The products are being recalled because they did not meet minimum needle attachment strength requirements. · FDA Class II
Units
Total 32,271 ea.
Sold at
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Description
The products are being recalled because they did not meet minimum needle attachment strength requirements.
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.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →