FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
- Recall number
- Z-1377-2013
- Recalling firm
- The Anspach Effort, Inc.
- Product
- ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
- Status
- Terminated
- Initiated
- 2011-03-04
- Posted
- 2013-05-24
- Terminated
- 2013-12-17
- Reason
- Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
- Root cause
- Labeling mix-ups
- Action
- Anspach 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
- 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.
- Lot, serial or model codes
- Lots numbers: D433040800, D403040236, D383039472.
- 510(k) numbers
- ["K113476"]
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28