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U.S. Department of Health and Human Services

Class 2 Device Recall 3mm Diamond Ball

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  Class 2 Device Recall 3mm Diamond Ball see related information
Date Initiated by Firm March 04, 2011
Date Posted May 24, 2013
Recall Status1 Terminated 3 on December 17, 2013
Recall Number Z-1377-2013
Recall Event ID 64886
510(K)Number K113476  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ***REF S-3D*** 3mm Diamond Ball.

Used for cutting and shaping bone.
Code Information Lots numbers: D433040800, D403040236, D383039472. 
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Denise DeLuigi
561-494-3711
Manufacturer Reason
for Recall		 Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
FDA Determined
Cause 2		 Labeling mix-ups
Action Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.
Quantity in Commerce 1,827 burrs
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
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 = HBE and Original Applicant = THE ANSPACH EFFORT, INC.
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