Passer, Wire, Orthopedic

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stab

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Sur

The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.

PERPOS PLS SYSTEM, CATALOG NO. 9045-01

This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw

PERPOS PLS SYSTEM, CATALOG NO. 9045-02

This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw

EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055.

The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.

The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.

The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System

The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.