Recall Z-0418-2026— Zimmer, Inc.

Name: FDA recall Z-0418-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2025-09-26. It names one FDA 510(k) clearance: K190656. Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis. Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-26
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

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis

Reason for recall

Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

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