Zimmer Biomet, Inc. recalls Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Spe…

Recall date

February 28, 2017

Source

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

Recall number

Z-2573-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapor…

Why it was recalled

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

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

What was recalled

Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants