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Offset Reamer Handle
- Starting date:
- November 14, 2016
- Posting date:
- November 25, 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-61224
Reason
Greatbatch Medical identified an issue with its Offset Reamer Handle, as field complaints were reported that the drive chain mechanism seizes during use. The function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during total hip arthroplasty. During seizing, the device is rendered non-functional in the operating room.
Affected products
Offset Reamer Handle
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00780408000
Companies
- Manufacturer
-
Greatbatch Medical
10000 Wehrle Drive
Clarence
14031
UNITED STATES