***REF S-3D*** 3mm Diamond Ball. Used for cutting and recall
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Why was ***REF S-3D*** 3mm Diamond Ball. Used for cutting and recalled?
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots numbers: D433040800, D403040236, D383039472.
- Product
- ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 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.
- Recall date
- June 5, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)