Z-1495-2017 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
March 29, 2017
Initiation Date
February 14, 2017
Termination Date
November 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3232

Product Description

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

Reason for Recall

Digital templates were created with the incorrect files.

Distribution Pattern

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, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Code Information

Orthosize Templating Version 1.2.6