The Anspach Effort, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1377-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 4, 2011

Date Posted: June 5, 2013

Recall Number: Z-1377-2013

Event ID: 64886

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.

Status: Terminated

Product Quantity: 1,827 burrs

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.

Voluntary or Mandated:

Voluntary: Firm initiated