Hip bearings recalled because size F packages contain size G implants

Plain-English summary

The Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing, 28 mm I.D., 44 mm O.D., Size F, catalog number 110031012, a semi-constrained hip prosthesis component, is being recalled.

Zimmer Biomet is recalling two 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.

The recall covers 72 units from lot 67160480, carrying UDI 00889024572706, distributed in Ohio, Georgia, Wisconsin, Nebraska, Iowa, Illinois, California, New York, Maryland, North Carolina, Pennsylvania, Alabama, Tennessee, Michigan, Washington, Florida, Texas, Kansas, New Mexico and Arizona, and to Canada and Australia. The FDA has classified the action as Class II.

The enforcement record describes the size mismatch and reports no injuries. Facilities should quarantine affected lots and follow Zimmer's instructions.

The recalled product

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

Manufacturer

Zimmer, Inc.

Category

Medical Device — Orthopedic implant

Hazard

• component-mismatch
• mislabeled-size
• implant
• packaging-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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