FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
- Recall number
- Z-0715-2014
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
- Status
- Terminated
- Initiated
- 2012-03-29
- Posted
- 2014-01-10
- Terminated
- 2017-10-12
- Reason
- Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
- Root cause
- Error in labeling
- Action
- Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email customer.support@synthes.com or ProductSupportTeam@Synthes.com. For questions regarding this recall call 561-627-1020.
- Quantity
- 492 (321 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
- Lot, serial or model codes
- ALL LOTS for product code 18-0001
- 510(k) numbers
- ["K042783"]
- 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