Recall Z-1495-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1495-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-14

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-02-14, terminated 2017-11-03. It names one FDA 510(k) clearance: K120115. Product: Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.. Reason: Digital templates were created with the incorrect files..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Terminated: 2017-11-03
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K120115 — ORTHOSIZEOrthosize, LLC·cleared 2012-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Digital templates were created with the incorrect files.

Data sourced from openFDA. This site is unofficial and independent of the FDA.