Recall Z-1947-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-1947-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-05-28, terminated 2021-11-19. FDA's recall record names no specific 510(k) clearance for this event. Product: DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.. Reason: There is a potential for weak seals of the sterile packaging..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2021-11-19
Firm location: Warsaw, IN, United States

Product description

DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

Reason for recall

There is a potential for weak seals of the sterile packaging.

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