Device product
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Z-1495-2017
Product summary
- Event
- Event 76442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3232
- Official record key
device-enforcement:Z-1495-2017
Official wording
Reason: Digital templates were created with the incorrect files.
Code information: Orthosize Templating Version 1.2.6
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.
Derived failure modes
-
Unknown
Digital templates were created with the incorrect files.