Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic su

FDA device recall Z-1495-2017 · posted 2017-03-13 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Digital templates were created with the incorrect files.

Action taken

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

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

LLZ

Quantity affected

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, Lithua

Date initiated

2017-02-14

Date posted

2017-03-13

Date terminated

2017-11-03

Location

Warsaw, IN

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