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
FDA Recall Z-1496-2012 · Posted 2012-05-08
Recalling FirmDoctor's Research Group, Inc.
Recall StatusTerminated
Product CodeGXP
Date Initiated2012-04-06
Date Terminated2015-07-14
Product Quantity3100 kits
Reason for Recall
Bone cement strength and stiffness fall below specification at body temperature
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
USA Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.