FDAClass IIOctober 14, 2020

Dual Mobility Vivacit-E Bearing recall

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Why was Dual Mobility Vivacit-E Bearing recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 64755636

Product
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Recalling firm
Zimmer Biomet, Inc.
Quantity
31
Distribution
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.
Recall date
October 14, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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