Recall Z-0730-2014 ยท MBB Bone Cement, Antibiotic
Zimmer, Inc.
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.
| Date | Jan 13, 2014 (initiated Nov 4, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Zimmer sent an Urgent Device Removal letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, idetntify the product and remove from use. If the affected product has been utilized, follow institutional protocol to determine if it is appropriate to place a copy of the notification letter into patient records for the affected product. Complete the attached Response Form and return it via fax to 800-871-7270. Customers were instructed to return a |
| Quantity | 1,534 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031673 | REFOBACIN -PALACOS G Heraeus Kulzer GmbH & Co. KG, May 25, 2004 |