Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Me

FDA device recall Z-0730-2014 · posted 2014-01-13 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MBB

Quantity affected

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.

Date initiated

2013-11-04

Date posted

2014-01-13

Date terminated

2014-10-08

Location

Warsaw, IN

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