Zimmer Screws (2016-05-06)

Starting date:

May 6, 2016

Posting date:

May 30, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-58608

• Reason
• Affected products

Affected products 

A. COMPRESSION SCREW

B. MAGNA-FX CANNULATED SCREW FIXATION SYSTEM AND INSTRUMENTATION

C. TRILOGY ACETABULAR SYSTEM-BONE SCREWS

D. COMPRESSION SCREW

 

Reason

These screws are packaged with a double barrier system, two plastic trays and two Tyvek lids, to provide sterile integrity. Process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray. The holes were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. The outer tray is not affected and the device's sterile integrity remains until the outer tray is opened. No product complaints have been reported for this issue.

Affected products