—#148362

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.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110290
Affected lot / code info: Catalog No. 0930-9-003

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide

Timeline

Recall initiated: 2016-07-01
Posted by FDA: 2016-08-11
Terminated: 2017-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148362. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.