Z-2396-2016Class II

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

Name: Z-2396-2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-07-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-07-01 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps... on 2016-07-01. FDA classified it as Class II and gives the reason as "Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2396-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-08-11
Terminated: 2017-06-08
Recalling firm: Howmedica Osteonics Corp
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.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 241 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Catalog No. 0930-9-003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2396-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2396-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code JDI

K110290Class IIExeter Hip StemHowmedica Osteonics Corp. / cleared 2011-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)