Mar

2017

Cl II Zimmer Biomet Orthosize Templating

Company: Zimmer Biomet, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Recall Number Z-1495-2017

REASON
Digital templates were created with the incorrect files.

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc., Warsaw, IN on 2/14/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3232

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Zimmer Biomet Orthosize Templating

Amy Sellers

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