Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1143-03 · Posted 2003-08-21

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeHTZ
Date Initiated2003-07-17
Date Terminated2003-09-03
Product Quantity102

Reason for Recall

Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.

Firm 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.

Root Cause

Other

Distribution Pattern

The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.

Official Source

View FDA Recall →

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

↑