Medical device recalls Moderate risk

Zimmer Manufacturing B.V. recalls Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 472347…

Recall date
May 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1676-2016
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

Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116

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