FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1496-2012
- 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
- Status
- Terminated
- Initiated
- 2012-04-06
- Posted
- 2012-05-08
- Terminated
- 2015-07-14
- 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
- Lot, serial or model codes
- All Lot Codes within expiration date distributed between January 2010 through April 2012. Lot Numbers: 02120422; 03092011; 05042011; 08112011; 04062011; 04072011; 08102011; 01162012
- 510(k) numbers
- ["K091382"]
- PMA numbers
- not on file
- Product code
- GXP
- Firm FEI
- 3002522629
- Firm city
- Southbury
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28