RecallRadar

FDA Device recall Z-2396-2016

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

On 2016-08-17 the FDA classified a Class II recall of Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system by Stryker Howmedica Osteonics, citing malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2396-2016
ClassificationClass II
Statusterminated
Initiated2016-07-01
Published2016-08-17
Last updated2026-09-13 11:54 UTC
CompanyStryker Howmedica Osteonics
DistributionUS

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.

Reason

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

Identifiers

code_infoCatalog No. 0930-9-003

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2396-2016%22

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