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Recall Observatory FDA recall evidence

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

July 01, 2016

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
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

    reason.no_named_rule · v1.0.0

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