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.
- Recall Initiated
- July 1, 2016
- Posted
- August 11, 2016
- Terminated
- June 8, 2017
- Recall Number
- Z-2396-2016
- Quantity
- 241 units
- Firm Location
- Mahwah, NJ
Reason for Recall
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Catalog No. 0930-9-003
Root Cause
Device Design
Action Taken
Stryker notified Branches/Agencies of the Urgent Medical Device Recall by e-mail on July 1, 2016 and an "Urgent Medical Device Recall Letter and Business Reply Form" was sent to branches, agents and hospital risk management via UPS (with return receipt) on July 5, 2016. The letter identified then affected product, problem and actions to be taken. For questions call (201) 831-6693.
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