Z-0964-2014Class II

Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica...

Name: Z-0964-2014 Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-11-20
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-11-20 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA... on 2013-11-20. FDA classified it as Class II and gives the reason as "Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0964-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2014-02-10
Terminated: 2016-10-13
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013
Quantity in commerce: 211 units
Distribution: IL MA, MN, ND, OR, & PA
Product codes and lots: Catalog no. 2124-1400 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0964-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0964-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)