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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description PalacosĀ® 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.
Recall Number Z-0730-2014
Classification Class II
Code Info Cat No. 00-1113-140-01; lot 75974340
Product Distributed Qty 1,534 units
Reason For Recall The 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.

Event Detail

Event Id 66990
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide 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.