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Terminated

Crossfire Acetabular II Insert. Catalog No: 2041C-2642.

FDA Recall Z-0560-04 · Posted 2004-07-20

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeJDL
Date Initiated2004-01-09
Date Terminated2004-03-08
Product Quantity3 (1 unit in US)

Reason for Recall

This device is not approved for sale in the US.

Firm Action

Letters dated 1/9/2004 and 1/12/2004 were sent to Surgical Resources and Dr. Vorenkamp alerting them to the situation.

Root Cause

Other

Distribution Pattern

The one device was shipped to Surgical Resources, 1150 Torrey Road, Suite A, Fenton, MI 48430 for Dr. Steven E. Vorenkamp, M.D., Petoskey, MI..

Official Source

View FDA Recall →

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

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