Atlas FDA

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

FDA device recall Z-0560-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Stryker Howmedica Osteonics
Reason for recall
This device is not approved for sale in the US.
Action taken
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
Status
Terminated
Product code
JDL
Quantity affected
3 (1 unit in US)
Distribution
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..
Date initiated
2004-01-09
Date posted
2004-07-20
Date terminated
2004-03-08
Location
Mahwah, NJ

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