FDA-Device2017-03-29Class II
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Zimmer Biomet, Inc.
Hazard
Digital templates were created with the incorrect files.
Sold states
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.
Affected count
3232
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief