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U.S. Department of Health and Human Services

Class 2 Device Recall Kryptonite Bone Cement

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  Class 2 Device Recall Kryptonite Bone Cement see related information
Date Initiated by Firm April 06, 2012
Date Posted May 08, 2012
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-1496-2012
Recall Event ID 61709
510(K)Number K091382  
Product Classification Methyl methacrylate for cranioplasty - Product Code GXP
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
Code Information All Lot Codes within expiration date distributed between January 2010 through April 2012.  Lot Numbers: 02120422; 03092011; 05042011; 08112011; 04062011; 04072011; 08102011; 01162012
Recalling Firm/
Manufacturer		 Doctor's Research Group, Inc.
574 Heritage Rd
Southbury CT 06488-1868
For Additional Information Contact
203-262-9335 Ext. 11
Manufacturer Reason
for Recall		 Bone cement strength and stiffness fall below specification at body temperature
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXP and Original Applicant = DOCTORS RESEARCH GROUP, INC.
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