Z-0349-2008

Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Axya Medical, Inc., Beverly, MA...

Name: Z-0349-2008 Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Axya Medical, Inc., Beverly, MA...
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 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, 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-0349-2008
Status: Terminated
Initiated: 2007-09-27
Posted: 2007-12-08
Terminated: 2012-06-21
Recalling firm: TORNIER Inc.
Product: Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, 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: 2,217 units
Distribution: Nationwide
Product codes and lots: Lot numbers: 203716, 203717, 203721, 203899, 20408, 204109, 204373 204374, 204375, 204467, 204468, 204622, 204926 and 204927

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)