Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1143-03

Femoral Resection Guide, Scorpio L.R.S. Instrumentation

Howmedica Osteonics Corp / initiated 2003-07-17 / Terminated

Stryker Howmedica Osteonics began a recall of Femoral Resection Guide, Scorpio L.R.S. Instrumentation on . The reason FDA records is "Scorpio Femoral Resection Guides have the potential to remove more bone than necessary". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1143-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Howmedica Osteonics Corp
Product
Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
Product code
HTZ Instrument, Cutting, Orthopedic
Reason for recall
Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.
FDA root cause
Other
Action
Product recall letters and product accountability forms were sent via FedEx to all Branches/sales agents on July 17, 2003. For the Canadian and International customers, the recall notification was also sent on July 17, 2003. All devices are to be returned to Howmedica Osteonics, Mahwah, NJ.
Quantity in commerce
102
Distribution
The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
Product codes and lots
Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113.