Omnilife Science Inc. recalls Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to…

Recall date

June 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2455-2015

FDA classification

Class II

Brand / firm

Omnilife Science Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems