Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP
FDA device recall Z-1496-2012 · posted 2012-05-08 · Terminated
Recall details
- Recalling firm
- Doctor's Research Group, Inc.
- Reason for recall
- Bone cement strength and stiffness fall below specification at body temperature
- Action taken
- 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
- Status
- Terminated
- Product code
- GXP
- Quantity affected
- 3100 kits
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2012-04-06
- Date posted
- 2012-05-08
- Date terminated
- 2015-07-14
- Location
- Southbury, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |