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Recall Observatory FDA recall evidence

Device product

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Z-0057-2021

August 14, 2020

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 86404
Status
Terminated
Classification
Class II
Quantity
31
Official record key
device-enforcement:Z-0057-2021

Official wording

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

Code information: Lot Number 64755636

Distribution pattern: Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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