FDAFDA · Food and drugs·Recall number Z-1495-2017
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Published March 29, 2017 · Recall initiated: February 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Digital templates were created with the incorrect files.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- 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.
- Lot
- Orthosize Templating Version 1.2.6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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