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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Carbide Cutting Burrs

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 Class 2 Device Recall Anspach Carbide Cutting Burrssee related information
Date Initiated by FirmDecember 17, 2013
Date PostedJanuary 13, 2014
Recall Status1 Terminated 3 on May 09, 2016
Recall NumberZ-0726-2014
Recall Event ID 67146
510(K)NumberK080802 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductAnspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Code Information All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18) 
FEI Number 1045834
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information ContactCustomer Support
800-327-6887
Manufacturer Reason
for Recall		Some carbide cutting burr fractured during use.
FDA Determined
Cause 2		Process design
ActionThe firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: customer.support@synthes.com. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate . Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at customer.support@synthes.com.
Quantity in Commerce28,562 total of all products in this recall
DistributionWorldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
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 = HBE
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