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Terminated

Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.

FDA Recall Z-2120-2010 · Posted 2010-08-02

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-05
Date Terminated2012-08-28
Product Quantity682 units in US, 1292 units internationally.

Reason for Recall

One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.

Firm Action

Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada.

Official Source

View FDA Recall →

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

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