Recalls / —

—#119554

Product

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

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

DeRoyal Industries Inc

Address

200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern

USA Nationwide Distribution in the state of PA

Timeline

Recall initiated

2013-05-30

Posted by FDA

2013-07-11

Terminated

2013-07-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #119554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.