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Zimmer, Inc. Recall: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin

Zimmer, Inc. Recall: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zimmer, Inc.; Product: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Metha

Recalling firmZimmer, Inc.
ProductPalacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Reason for recallThe patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.
Recall initiated20131104
Recall numberZ-0730-2014
Categorydevice
StateIN
CountryUnited States

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