Recall Z-1188-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200.
| Date | Mar 22, 2010 (initiated Jan 14, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type. |
| Root cause | Process control |
| Action | The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966. |
| Quantity | 144 |
| Distribution | Nationwide and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021008 | ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL Advanced Orthopaedic Solutions, Inc., Jun 20, 2002 |