Z-1190-2010

AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200

Name: Z-1190-2010 AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200
Creator: Advanced Orthopaedic Solutions Inc
Published: 2010-01-14
License: https://open.fda.gov/license/

Advanced Orthopaedic Solutions, Inc. / initiated 2010-01-14 / Terminated / root cause: manufacturing process

FDA source

Advanced Orthopaedic Solutions Inc began a recall of AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200 on 2010-01-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1190-2010
Status: Terminated
Initiated: 2010-01-14
Posted: 2010-03-22
Terminated: 2012-04-26
Recalling firm: Advanced Orthopaedic Solutions, Inc.
Product: AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 160
Distribution: Nationwide and Japan
Product codes and lots: Lot Numbers: 08375, 08594, 09020, 09021, & 09022.

Product code HSB

K021008Class IIAdvanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. / cleared 2002-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)