Z-0730-2014 Class II Terminated
FDA device recall Z-0730-2014 was initiated by Zimmer, Inc. on Nov 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 1,534 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Nov 4, 2013
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,534 units
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.
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.
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.
Code Information
Cat No. 00-1113-140-01; lot 75974340
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0730-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026