—#124437

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.

FDA product code: MBB — Bone Cement, Antibiotic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K031673
Affected lot / code info: Cat No. 00-1113-140-01; lot 75974340

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 copy of the completed response form along with their returned product to ensure proper credit. Customers with questions were instructed to call 866-608-3941. For questions regarding this recall call 800-613-6131.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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.

Timeline

Recall initiated: 2013-11-04
Posted by FDA: 2014-01-13
Terminated: 2014-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.