FDA Device

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

Hazard

DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

What You Should Do

Remedy

DeRoyal sent an Urgent: Voluntary Product Recall letter dated May 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, remove any affected product from their inventory, open its package to prevent use, and dispose in a standard trash receptacle. Customers were asked to complete the enclosed notice of destruction form and return it to DeRoyal by faxing it to 865-362-3716 or emailing it to recalls@deroyal.com. For question call 865-362-1034 or contact your DeRoyal representative.

Products

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Brand
DeRoyal Industries Inc
UPC
Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366

Units Affected

87 units