Zimmer, Inc. recalls Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic im…

Recall date

December 8, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0900-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Distributed to MI, KS, and CA.

Why it was recalled

Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.

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

What was recalled

Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.