FDA Medical Device Recalls (openFDA)
Advanced Orthopaedic Solutions Inc: AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.
- Recall number
- Z-1190-2010
- Recalling firm
- Advanced Orthopaedic Solutions Inc
- Product
- AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.
- Status
- Terminated
- Initiated
- 2010-01-14
- Posted
- 2010-03-22
- Terminated
- 2012-04-26
- 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
- 160
- Distribution
- Nationwide and Japan
- Lot, serial or model codes
- Lot Numbers: 08375, 08594, 09020, 09021, & 09022.
- 510(k) numbers
- ["K021008"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3009833755
- Firm city
- Torrance
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28