AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200.
FDA device recall Z-1182-2010 · posted 2010-03-22 · Terminated
Recall details
- Recalling firm
- Advanced Orthopaedic Solutions Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 30
- Distribution
- Nationwide and Japan
- Date initiated
- 2010-01-14
- Date posted
- 2010-03-22
- Date terminated
- 2012-04-26
- Location
- Torrance, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL (K021008) | Advanced Orthopaedic Solutions, Inc. | 2002-06-20 |