Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic s…

Recall date
February 14, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1495-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Worldwide distribution. US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapo…

Why it was recalled

Digital templates were created with the incorrect files.

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

What was recalled

Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.

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