Z-1495-2017Class II

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

Name: Z-1495-2017 Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of...
Creator: Zimmer Biomet, Inc.
Published: 2017-02-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-02-14 / Terminated / root cause: software

FDA source

Zimmer Biomet, Inc. began a recall of Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery on 2017-02-14. FDA classified it as Class II and gives the reason as "Digital templates were created with the incorrect files". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1495-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Posted: 2017-03-13
Terminated: 2017-11-03
Recalling firm: Zimmer GmbH
Product: Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Digital templates were created with the incorrect files.
Root cause tag: software
FDA 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 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 [email protected] 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 [email protected]. 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 [email protected]
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.
Product codes and lots: Orthosize Templating Version 1.2.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code LLZ

K120115Class IIOrthosizeOrthosize, LLC / cleared 2012-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)