Z-1071-2010

DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker...

Name: Z-1071-2010 DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker...
Creator: DeRoyal Industries Inc
Published: 2009-12-09
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2009-12-09 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit on 2009-12-09. The reason FDA records is "Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility". 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-1071-2010
Status: Terminated
Initiated: 2009-12-09
Posted: 2010-03-11
Terminated: 2010-05-20
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.
Product code: LRO General Surgery Tray
Reason for recall: Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009
Quantity in commerce: 194 units
Distribution: LA & MS
Product codes and lots: Lot numbers: 08150012, 08156012, 08172012, 08192012, 08221012, 08247012, 08249012, 08302012, 08270012, 08312012, 08354012, 09022012, and 08354012

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