Z-0354-2008

Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065...

Name: Z-0354-2008 Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065...
Creator: Axya Medical
Published: 2007-09-27
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2007-09-27 / Terminated / root cause: packaging

FDA source

Axya Medical began a recall of 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 on 2007-09-27. The reason FDA records is "Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0354-2008
Status: Terminated
Initiated: 2007-09-27
Posted: 2007-12-08
Terminated: 2012-06-21
Recalling firm: TORNIER Inc.
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
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Root cause tag: packaging
FDA 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 in commerce: 1,538 units
Distribution: Nationwide
Product codes and lots: 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

Product code MBI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)