Teleflex Medical: Medical Device Recall in 2014 - (Recall #: Z-1295-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 11, 2014

Date Posted: April 2, 2014

Recall Number: Z-1295-2014

Event ID: 67733

Reason for Recall:

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

Status: Terminated

Product Quantity: Total 32,271 ea.

Code Information:

Product Code: X-4981M4, Lot number: 02J0800451

Distribution Pattern:

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Voluntary or Mandated:

Voluntary: Firm initiated