Comprehensive Shoulder System Primary Mini and Primary Length Shoulder Stem (2017-12-21)

Starting date:

December 21, 2017

Posting date:

May 1, 2018

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-66638

• 
  Reason
• 
  Affected products

Affected products

1. Comprehensive Shoulder System Primary Mini Length Shoulder Stem
2. Comprehensive Shoulder System Primary Micro Length Shoulder Stem

Reason

Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems in the table above. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

Affected products