FDA Medical Device Recalls (openFDA)
Axya Medical: Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1266, Axya Medical, Inc., Beverly, MA 01915
- Recall number
- Z-0342-2008
- Recalling firm
- Axya Medical
- Product
- Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1266, Axya Medical, Inc., Beverly, MA 01915
- Status
- Terminated
- Initiated
- 2007-09-27
- Posted
- 2007-12-08
- Terminated
- 2012-06-21
- Reason
- Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Root cause
- Package design/selection
- Action
- Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.
- Quantity
- 111 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 204677, 204800, 204826 and 204838
- 510(k) numbers
- ["K051983","K052491","K060970"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3000718467
- Firm city
- Beverly
- Firm state
- MA
- 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