Z-1692-2013Class II

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE

Name: Z-1692-2013 GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE
Creator: DeRoyal Industries Inc
Published: 2013-05-30
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2013-05-30 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical on 2013-05-30. FDA classified it as Class II and gives the reason as "DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-07-11
Terminated: 2013-07-12
Recalling firm: DeRoyal Industries, Inc.
Product: GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Product code: LRO General Surgery Tray
Reason for recall: DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected]. For question call 865-362-1034 or contact your DeRoyal representative.
Quantity in commerce: 87 units
Distribution: USA Nationwide Distribution in the state of PA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)