FDA Medical Device Recalls (openFDA)
Axya Medical: Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915
- Recall number
- Z-0352-2008
- Recalling firm
- Axya Medical
- Product
- Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , 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
- 4,091 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 203766 203768 203788 203857 203858 203859 203879 203884 203885 203918 203919 203925 203931 203932 203969 204009 204129 204174 204185 204186 204218 204219 204224 204234 204235 204240 204241 204257 204258 204259 204267 204268 204269 204274 204275 204276 204296 204311 204312 204313 204324 204325 204326 204327 204328 204329 204382 204429 204456 204457 204597 204598 204606 204615 204616 204617 204618 204699 204700 204701 and 204702
- 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