ClearanceBrief
Recall Z-1143-03 ยท HTZ Instrument, Cutting, Orthopedic

Stryker Howmedica Osteonics

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

DateAug 21, 2003 (initiated Jul 17, 2003)
StatusTerminated
ReasonScorpio Femoral Resection Guides have the potential to remove more bone than necessary.
Root causeOther
ActionProduct 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.
Quantity102
DistributionThe catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.