FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
- Recall number
- Z-1574-2014
- Recalling firm
- The Anspach Effort, Inc.
- Product
- ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
- Status
- Terminated
- Initiated
- 2014-01-08
- Posted
- 2014-05-09
- Terminated
- 2015-01-20
- Reason
- Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
- Root cause
- Labeling mix-ups
- Action
- Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.
- Quantity
- 30 cutting burs affected
- Distribution
- Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
- Lot, serial or model codes
- Lot/Set/Serial: G323081803.
- 510(k) numbers
- ["K011444"]
- PMA numbers
- not on file
- Product code
- HTT
- 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