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U.S. Department of Health and Human Services

Class 2 Device Recall Hemostatic Bone Putty

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  Class 2 Device Recall Hemostatic Bone Putty see related information
Date Initiated by Firm January 06, 2012
Date Posted February 11, 2015
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-1094-2015
Recall Event ID 70055
510(K)Number K113079  
Product Classification Wax,bone - Product Code MTJ
Product Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Code Information Part 10847A
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.
FDA Determined
Cause 2		 Labeling mix-ups
Action On/about 12/22/2011, emails containing Revision B brochure, as well as instructions to delete/destroy Revision A, were sent to 38 affected individuals (sales consultants). On/about 1/04/2012, follow up phone calls were made to each member of the sales force who had received Rev. A (110847 A) to confirm that they had replaced the Rev. A with the Rev. B (110847 B). In addition, the members of the sales force were asked whether or not the Rev. A had been disseminated to any HCP's. During the follow up conversation, one member of the sales force stated that he had provided the previous version to a surgeon. On 01/06/2012, the sales consultant spoke to the surgeon in person and the surgeon confirmed that he had disposed of the Rev. A.
Quantity in Commerce 38
Distribution Distributed in the state of WI
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 = MTJ and Original Applicant = SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
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