Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings

510(k) K190656

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK190656	Date6 Dec 2019Cleared	StatusActive

3 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0418-2026 FDA Class II initiated 26 Sep 2025
- Ongoing Z-0419-2026 FDA Class II initiated 26 Sep 2025
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.
- Terminated Z-0057-2021 FDA Class II initiated 14 Aug 2020
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

1 jurisdiction

United States — FDA 510(k) Active

510(k)