Reported Aug 17, 2016 · Terminated

Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter…

Stryker Howmedica Osteonics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • Orthopedic
  • manual surgical instrument UsageExeter 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
Lot codes and dates
  • Catalog No. 0930-9-003
Amount recalled
241 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 8, 2017 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.