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Terminated

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

FDA Recall Z-0964-2014 · Posted 2014-02-10

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-11-20
Date Terminated2016-10-13
Product Quantity211 units

Reason for Recall

Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.

Firm Action

Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013

Root Cause

Process design

Distribution Pattern

IL MA, MN, ND, OR, & PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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