Recall Z-0057-2021— Zimmer Biomet, Inc.

Name: FDA recall Z-0057-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-14

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2020-08-14, terminated 2022-06-09. It names one FDA 510(k) clearance: K190656. Product: Dual Mobility Vivacit-E Bearing, Model Number 110031009. Reason: The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Terminated: 2022-06-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.·cleared 2019-12-06

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

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Reason for recall

The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

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