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Recall Observatory FDA recall evidence

Device product

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

Z-1377-2013

March 04, 2011

Class II

Product summary

Firm
The Anspach Effort, Inc.
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

    reason.no_named_rule · v1.0.0

    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.