FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Anspach Single Use, Sterile Bone Cutting Burrs
- Recall number
- Z-1008-2007
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Anspach Single Use, Sterile Bone Cutting Burrs
- Status
- Terminated
- Initiated
- 2007-05-18
- Posted
- 2007-07-11
- Terminated
- 2009-01-17
- Reason
- The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
- Root cause
- Nonconforming Material/Component
- Action
- The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.
- Quantity
- 1,962,123
- Distribution
- World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.
- Lot, serial or model codes
- All cutting burrs packaged with an expiration date between June 2008 and august 2011.
- 510(k) numbers
- ["K011444","K061297","K955084","K965080"]
- PMA numbers
- not on file
- Product code
- HBB
- 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