Recall Z-1496-2012 ยท GXP Methyl Methacrylate For Cranioplasty
Doctor's Research Group, Inc.
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
| Date | May 8, 2012 (initiated Apr 6, 2012) |
| Status | Terminated |
| Reason | Bone cement strength and stiffness fall below specification at body temperature |
| 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 | 3100 kits |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091382 | KRYPTONITE BONE CEMENT Doctors Research Group, Inc., Nov 16, 2009 |