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U.S. Department of Health and Human Services

Class 2 Device Recall Orthosize

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  Class 2 Device Recall Orthosize see related information
Date Initiated by Firm February 14, 2017
Date Posted March 13, 2017
Recall Status1 Open3, Classified
Recall Number Z-1495-2017
Recall Event ID 76442
510(K)Number K120115  
Product Classification System, image processing, radiological - Product Code LLZ
Product Orthosize Templating Version 1.2.6
Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Code Information Orthosize Templating Version 1.2.6
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Digital templates were created with the incorrect files.
FDA Determined
Cause 2
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 affected personnel are aware its contents. 2. Immediately update the app when the update becomes available. 3. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com Digital Template Users (3rd party) 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately update your systems to include the revised digital templates included with notice. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your records. 4. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com
Quantity in Commerce 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, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ORTHOSIZE LLC
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