Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0560-04

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

Howmedica Osteonics Corp / initiated 2004-01-09 / Terminated

Stryker Howmedica Osteonics began a recall of Crossfire Acetabular II Insert. Catalog No: 2041C-2642 on . The reason FDA records is "This device is not approved for sale in the US". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0560-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Howmedica Osteonics Corp
Product
Crossfire Acetabular II Insert. Catalog No: 2041C-2642.
Product code
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Reason for recall
This device is not approved for sale in the US.
FDA root cause
Other
Action
Letters dated 1/9/2004 and 1/12/2004 were sent to Surgical Resources and Dr. Vorenkamp alerting them to the situation.
Quantity in commerce
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..
Product codes and lots
Lot 48921601