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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 Ballsee related information
Date Initiated by FirmMarch 04, 2011
Date PostedMay 24, 2013
Recall Status1 Terminated 3 on December 17, 2013
Recall NumberZ-1377-2013
Recall Event ID 64886
510(K)NumberK113476 
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 ContactDenise 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
ActionAnspach 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 Commerce1,827 burrs
DistributionWorldwide 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 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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