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TANDEM INTL BIPOLAR SHELL/LINER
- Starting date:
- September 6, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-60360
Affected products
Reason
The affected devices were manufactured with an out of specification retainer groove location. In the event the failure occurs, it would be obvious to the user in that the devices would not provide an audible indicator that the poly lock has engaged. In the event the construct is tight, the user should notice the limited range of motion. However, in the worst case situation, if the device gives a false indicator of locking, the user would not recognize the failure.
Affected products
TANDEM INTL BIPOLAR SHELL/LINER
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES