Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Axya Medical, Inc., Beverly, MA 01915
FDA device recall Z-0344-2008 · 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
- 329 units
- Distribution
- Nationwide
- Date initiated
- 2007-09-27
- Date posted
- 2007-12-08
- Date terminated
- 2012-06-21
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXYALOOP NONABSORBABLE BONE ANCHOR (K060970) | Axya Medical, Inc. | 2006-07-05 |
| AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR (K052491) | Axya Medical, Inc. | 2005-10-07 |
| MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K051983) | Axya Medical, Inc. | 2005-08-05 |