Z-1495-2017 Class II Terminated
FDA device recall Z-1495-2017 was initiated by Zimmer Biomet, Inc. on February 14, 2017 and is designated Class II. Reason for recall: Digital templates were created with the incorrect files. The recall status is terminated (terminated November 3, 2017). Affected quantity: 3232.
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