Axya Anchor, 5.0 mm Titanium in Super Kit, Catalog Number: CAT1270, Axya Medical, Inc., Beverly, MA 01915
FDA device recall Z-0336-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Axya Medical
- Reason for recall
- Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 208 units
- Distribution
- Nationwide
- Date initiated
- 2007-09-27
- Date posted
- 2007-12-08
- Date terminated
- 2012-06-21
- Location
- Beverly, MA
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