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

Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

FDA Recall Z-2454-2015 · Posted 2015-08-24

Recalling FirmOmnilife Science Inc.
Recall StatusTerminated
Product CodeFZX
Date Initiated2015-06-09
Date Terminated2015-09-28
Product Quantity15

Reason for Recall

The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

Firm Action

Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.

Official Source

View FDA Recall →

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

↑