PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 29, 2017 Initiated: February 14, 2017 #Z-1495-2017

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
3232
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.. Recalled by Zimmer Biomet, Inc.. Units affected: 3232.
Why was this product recalled?
Digital templates were created with the incorrect files.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1495-2017.