FDA-Device2016-08-17Class II

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.

Stryker Howmedica Osteonics Corp.
Hazard

Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.

Sold states
Worldwide Distribution - US Nationwide
Affected count
241 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2016

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