Recall Z-1692-2013— DeRoyal Industries Inc

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2013-05-30, terminated 2013-07-12. FDA's recall record names no specific 510(k) clearance for this event. Product: GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical. Reason: DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization..

Recalling firm
DeRoyal Industries Inc
Classification
Class II
Status
Terminated
Initiated
2013-05-30
Terminated
2013-07-12
Firm location
Powell, TN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.