FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
- Recall number
- Z-2298-2015
- Recalling firm
- The Anspach Effort, Inc.
- Product
- ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
- Status
- Terminated
- Initiated
- 2015-04-13
- Posted
- 2015-07-29
- Terminated
- 2016-08-25
- Reason
- G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
- Root cause
- Device Design
- Action
- Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.
- Quantity
- 70 tools.
- Distribution
- Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
- Lot, serial or model codes
- REF M-6DC-2-G1 ; ALL lot numbers
- 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