Recall Z-1188-2010
Advanced Orthopaedic Solutions Inc · initiated January 14, 2010
Product
AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200.
Codes / lots: Lot Numbers: 08374, 08593, & 09018.
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1188-2010
- Initiated
- January 14, 2010
- Posted by FDA
- March 22, 2010
- Terminated
- April 26, 2012
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 144
- Distribution
- Nationwide and Japan
- Recalling firm
- Advanced Orthopaedic Solutions Inc, Torrance, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1181-2010 | AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number: 1034-170.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1182-2010 | AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1183-2010 | AOS Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1184-2010 | AOS Trochanteric Nail, 11mm x 20cm x 130, Product Part Number: 1036-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1186-2010 | AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1187-2010 | AOS Trochanteric Nail, 10mm x 17cm x 130, Product Part Number: 1040-170The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1189-2010 | AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1190-2010 | AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1191-2010 | AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |
| Z-1192-2010 | AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200.The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect… | 01/14/2010Terminated |