Z-2396-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- July 1, 2016
- Termination Date
- June 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 241 units
Product Description
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.
Reason for Recall
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
Catalog No. 0930-9-003