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TORQUE LIMITING ATTACHMENT (2016-07-05)
- Starting date:
- July 5, 2016
- Posting date:
- July 22, 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-59492
Affected products
A. TORQUE LIMITING ATTACHMENT
Reason
Greatbatch Medical identified through testing that the required sterility assurance level is not achieved on these devices when subjected to steam sterilization cycles identified in the instruction for use (IFU) provided with the device. The torque limiting devices are supplied non-sterile and require cleaning and steam sterilization prior to use and subsequent re-use.
Affected products
A. TORQUE LIMITING ATTACHMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00-2360-080-00
00-2360-080-05
Companies
- Manufacturer
-
GREATBATCH MEDICAL
10000 WEHRLE DRIVE
CLARENCE
14031
New York
UNITED STATES