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Terminated

Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.

FDA Recall Z-2118-2010 · Posted 2010-08-02

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-05
Date Terminated2012-08-28
Product Quantity676 in US, 1305 internationally.

Reason for Recall

There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.

Firm Action

Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

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

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