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U.S. Department of Health and Human Services

Class 1 Device Recall Synthes(R) Hemostatic Bone Putty

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  Class 1 Device Recall Synthes(R) Hemostatic Bone Putty see related information
Date Initiated by Firm July 05, 2012
Date Posted August 16, 2012
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-2206-2012
Recall Event ID 62592
510(K)Number K113079  K103822  
Product Classification Wax,bone - Product Code MTJ
Product Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S.

Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
Code Information All lot numbers associated with the identified part numbers.
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
FDA Determined
Cause 2		 Labeling design
Action The firm initiated their recall of this product on July 5, 2012 by sending a "Notice: Medical Device Recall" letter to their consignees. The letter identified the affected product along with the reason for recall; and, requested that consignees immediately cease using the product, examine their inventory, and remove the product from inventory. The letter further instructed consignees to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, and to complete and return the verification form that was included with the letter. Questions should be directed to 610-719-5450.
Quantity in Commerce 8,853 packs
Distribution Worldwide Distribution -- US, including Washington, DC and states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI, and the country of Canada.
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
510(K)s with Product Code = MTJ and Original Applicant = SYNTHES USA PRODUCTS, LLC
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