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

FDA device recall Z-1692-2013 · posted 2013-07-11 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

87 units

Distribution

USA Nationwide Distribution in the state of PA

Date initiated

2013-05-30

Date posted

2013-07-11

Date terminated

2013-07-12

Location

Powell, TN