Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0730-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 4, 2013

Date Posted: January 22, 2014

Recall Number: Z-0730-2014

Event ID: 66990

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.

Status: Terminated

Product Quantity: 1,534 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated