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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 sterilesee related information
Date Initiated by FirmSeptember 14, 2009
Date PostedNovember 16, 2009
Recall Status1 Terminated 3 on March 08, 2010
Recall NumberZ-0269-2010
Recall Event ID 53496
510(K)NumberK060445 
Product Classification Methyl Methacrylate For Cranioplasty - Product Code GXP
ProductNorian 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 ContactLynne 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
ActionThe 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 Commerce15 units
DistributionThe product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GXP
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