This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Trabecular Reverse Shoulder Glenosphere and Base Plates (2013-10-18)

Starting date:
October 18, 2013
Posting date:
November 7, 2013
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-36641

Recalled Products

A. Trabecular Reverse Shoulder Glenosphere
B. Trabecular Reverse Shoulder Base Plates

Reason

Zimmer is initiating a product recall for the listed Zimmer trabecular metal reverse shoulder system glenosphere and base plate item numbers because it has received 90 complaints (complaint rate of 0.27%) related to the glenosphere disassociating from the base plate or difficulty assembling the glenosphere to the base plate. Based on the investigation of these complaints, Zimmer determined that additional instructions specific to the assembly of the glenosphere to the base plate were necessary in order to emphasize important techniques.

Affected products

A. Trabecular Reverse Shoulder Glenosphere
 

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number
  • 00-4349-036-11
  • 00-4349-040-11
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES

B. Trabecular Reverse Shoulder Base Plates

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number
  • 00-4349-038-11
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES