Recall Z-0338-2008 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Axya Medical
Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Axya Medical, Inc., Beverly, MA 01915
| Date | Dec 8, 2007 (initiated Sep 27, 2007) |
| Status | Terminated |
| 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 | 776 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.