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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