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Recall Observatory FDA recall evidence

Device product

Palacos¿ 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.

Z-0730-2014

November 04, 2013

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 66990
Status
Terminated
Classification
Class II
Quantity
1,534 units
Official record key
device-enforcement:Z-0730-2014

Official wording

Reason: 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.

Code information: Cat No. 00-1113-140-01; lot 75974340

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.