Device product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Z-1377-2013
Product summary
- Event
- Event 64886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,827 burrs
- Official record key
device-enforcement:Z-1377-2013
Official wording
Reason: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Code information: Lots numbers: D433040800, D403040236, D383039472.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.