FDA Medical Device Recalls (openFDA)
Axya Medical: Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915
- Recall number
- Z-0354-2008
- Recalling firm
- Axya Medical
- Product
- Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, 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
- 1,538 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 203767 203769 203809 203829 203839 203940 203941 203942 203953 203965 203966 203967 203968 204010 204018 204019 204130 204236 204242 204250 204251 204252 204284 204285 204286 204292 204293 204294 204295 204314 204315 204316 204356 204357 204358 204359 204360 204361 204368 204377 204379 204380 204400 204401 204412 204433 204434 204437 204438 204609 204610 204611 204624 204657 204667 204668 and 204669
- 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