Z-0197-2009

DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)

Name: Z-0197-2009 DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
Creator: DeRoyal Industries Inc
Published: 2008-10-01
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2008-10-01 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit) on 2008-10-01. The reason FDA records is "Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges". 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-0197-2009
Status: Terminated
Initiated: 2008-10-01
Posted: 2008-11-07
Terminated: 2009-12-02
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.
Quantity in commerce: 4 kits
Distribution: LA & KY
Product codes and lots: Lot numbers: 13819779, 14002496, and 14356032

Product code KDD

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)