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Fixion Nailing System
CARBOFIX ORTHOPEDICS LTD · Model Humeral Nail · UDI-DI 07290109330167
10
510(k) clearances
7,230
Adverse events (11 deaths)
21
Recalls
113
Facilities
Description
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. Includes nail cap.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | Synthes (USA) Products LLC | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46m |
| 2025-09-26 | Synthes (USA) Products LLC | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46m |
| 2022-04-22 | Smith & Nephew Orthopaedics GmbH | Right nails were anodized, marked, and labelled as left nails and vice versa |
| 2020-11-02 | Smith & Nephew, Inc. | Manufacturing packaging error. |
| 2020-06-24 | Smith & Nephew, Inc. | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
| 2017-10-24 | Smith & Nephew, Inc. | A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. |
| 2017-02-17 | Zimmer Biomet, Inc. | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
| 2015-06-03 | Synthes, Inc. | A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. |
| 2014-07-02 | Smith & Nephew, Inc. | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. |
| 2014-04-04 | Smith & Nephew Inc | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.