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
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
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.