Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect
Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional performance issue (lower cutting performance) rather than a direct safety hazard like infection or injury, and no illnesses or injuries are reported in the source text.
Plain-English summary
Orthofix Srl is recalling specific batches of the Tibia Femur Diaphyseal Sterile Kit (Catalogue Number: ref: 99-93502US, UDI: (01)18054242S511298). The recall was initiated after complaint investigations determined that the drill bits included in these kits have a geometrical detail that does not correspond to the intended design.
This design discrepancy could result in lower cutting performance. The affected lot number is B1225603. The products were distributed in the United States (including Puerto Rico) and in numerous countries outside the US, including Kuwait, Australia, Saudi Arabia, and others.
Healthcare providers and consumers should stop using the affected kits and contact Orthofix Srl for further instructions or a replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
- Manufacturer
- Orthofix Srl
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: B1225603
Distribution
Part of a larger recall action
This product is one of 31 recalled by Orthofix Srl under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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