Food, drugs, devices › DeRoyal Industries Inc
Device recall: GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
DeRoyal Industries Inc (Powell, TN) initiated this device recall on 30 May 2013; FDA lists 1 product record under event 65554, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 12 Jul 2013. Initiation: voluntary: firm initiated. DeRoyal Industries Inc has 46 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DeRoyal Industries Inc, Powell, TN.
Reason for recall
"DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization."
Distribution
"USA Nationwide Distribution in the state of PA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1692-2013 | GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical | 87 units | Class II | Terminated | 17 Jul 2013 |
Context
Other enforcement events for DeRoyal Industries Inc
All 46 events for DeRoyal Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA Nationwide Distribution in the state of PA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jul 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.