Various Zimmer 70cm Guide Wire Trauma Products (2017-06-14)

Starting date:

June 14, 2017

Posting date:

July 6, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63840

• 
  Reason
• 
  Affected products

Affected Products

A. M/DN Intramedullary Fixation Humeral Guide Wire

B. Humeral Guide Wire Ball Tip

C. Zimmer Natural Nail System Tear Drop Guide Wire

Reason

Zimmer is initiating a recall/removal for various 70cm guide wire trauma products which assist in guiding the nail during implantation. The humeral guide wire ball tip is also used to guide flexible reamers during ulna preparation for the nexel total elbow. The design verification for the previous packaging configuration does not cover the 70cm wires. While there have been no complaints involving a breach in sterility, Zimmer has completed design verification to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

Affected products