Z-2008-2012Class II

Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF...

Name: Z-2008-2012 Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF...
Creator: DeRoyal Industries Inc
Published: 2012-06-16
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2012-06-16 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits on 2012-06-16. FDA classified it as Class II and gives the reason as "Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the...". 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-2008-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-16
Posted: 2012-07-13
Terminated: 2012-11-09
Recalling firm: DeRoyal Industries, Inc.
Product: Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Product code: LRO General Surgery Tray
Reason for recall: Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.
Quantity in commerce: 303 units
Distribution: Nationwide Distribution including SD and NE.
Product codes and lots: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694 GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2008-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2008-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-13

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)