Recall Z-1495-2017 ยท LLZ System, Image Processing, Radiological
Zimmer Biomet, Inc.
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
| Date | Mar 13, 2017 (initiated Feb 14, 2017) |
| Status | Terminated |
| Reason | Digital templates were created with the incorrect files. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On 2/14/2017 URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected users and 3rd party users via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for 3rd party users to respond to the formal recall notification. Orthosize Templating Users In approximately 6 weeks you will receive a notice that an update is available for the Orthosize Templating App. Upon selecting the app you will be required to update the app in order to use it. 1. Review this notification and ensure affect |
| Quantity | 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, Singap |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120115 | ORTHOSIZE Orthosize, LLC, Mar 14, 2012 |