Device product
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Z-2396-2016
Product summary
- Event
- Event 74743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 241 units
- Official record key
device-enforcement:Z-2396-2016
Official wording
Reason: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Code information: Catalog No. 0930-9-003
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Unknown
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.