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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 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.
Recall Number Z-1295-2014
Classification Class II
Code Info Product Code: X-4981M4, Lot number: 02J0800451
Product Distributed Qty Total 32,271 ea.
Reason For Recall The products are being recalled because they did not meet minimum needle attachment strength requirements.

Event Detail

Event Id 67733
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
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