Z-1496-2012

Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05...

Name: Z-1496-2012 Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05...
Creator: Doctor's Research Group, Inc.
Published: 2012-04-06
License: https://open.fda.gov/license/

Doctor'S Research Group, Inc. / initiated 2012-04-06 / Terminated / root cause: design

FDA source

Doctor's Research Group, Inc. began a recall of Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage... on 2012-04-06. The reason FDA records is "Bone cement strength and stiffness fall below specification at body temperature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1496-2012
Status: Terminated
Initiated: 2012-04-06
Posted: 2012-05-08
Terminated: 2015-07-14
Recalling firm: Doctor'S Research Group, Inc.
Product: Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects
Product code: GXP Methyl Methacrylate For Cranioplasty
Reason for recall: Bone cement strength and stiffness fall below specification at body temperature
Root cause tag: design
FDA root cause: Component design/selection
Action: Doctors Research Group (DRG) issued a Voluntary Product Recall Notification letter dated April 2012 to all affected customers via email or Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify, segregate and return any affected products in their possession. Customers were asked to fill out and return the enclosed verification form Distributors were requested to notify their customers. For questions contact DRG at 203-262-9335.
Quantity in commerce: 3100 kits
Distribution: USA Nationwide Distribution
Product codes and lots: All Lot Codes within expiration date distributed between January 2010 through April 2012. Lot Numbers: 02120422; 03092011; 05042011; 08112011; 04062011; 04072011; 08102011; 01162012

Product code GXP

K091382Class IIKryptonite Bone CementDoctors Research Group, Inc. / cleared 2009-11-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)