Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296…

Recall date
October 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0319-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distributed nationwide.

Why it was recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200

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