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U.S. Department of Health and Human Services

Class 2 Device Recall Norian CRS Rotary Mixer Cement 10cc sterile

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  Class 2 Device Recall Norian CRS Rotary Mixer Cement 10cc sterile see related information
Date Initiated by Firm September 14, 2009
Date Posted November 16, 2009
Recall Status1 Terminated 3 on March 08, 2010
Recall Number Z-0269-2010
Recall Event ID 53496
510(K)Number K060445  
Product Classification Methyl Methacrylate For Cranioplasty - Product Code GXP
Product Norian CRS Rotary Mixer Cement 10cc sterile
Code Information Catalog number 614.10.01S. Lot number N996352
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Lynne Lewis
800-479-6329
Manufacturer Reason
for Recall		 Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Autho
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.
Quantity in Commerce 15 units
Distribution The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
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 = SYNTHES (USA)
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