Medical device recalls Moderate risk

Zimmer Manufacturing B.V. recalls VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400

Recall date
May 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1682-2016
FDA classification
Class II
Brand / firm
Zimmer Manufacturing B.V.
Sold / distributed
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

Why it was recalled

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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

What was recalled

VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400

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