FDA-Device2015-01-07Class II
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Zimmer, Inc.
Hazard
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.
Sold states
Distributed to MI, KS, and CA.
Affected count
40 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2015Don't want to check this manually?
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