Orthofix Recalls XCaliber Ankle Kits Due to Drill Bit Design Defect
Orthofix is recalling XCaliber Ankle Complete Kits because drill bits have a design defect that may reduce 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, and the hazard is a performance issue (lower cutting performance) rather than a direct risk of serious injury or death, fitting the Moderate category for low-risk defects without reported harm.
Plain-English summary
Orthofix Srl is recalling specific batches of the US XCaliber Ankle Complete Kit (Catalogue Number 99-91647). The recall was initiated after complaint investigations revealed that the drill bits included in these kits have a geometrical detail that does not match the intended design.
This design discrepancy could result in lower cutting performance during surgical procedures. The affected lots are B1201157, B1203789, and B1226060. The product was distributed in numerous US states and internationally, including in Kuwait, Australia, and the United Arab Emirates.
Healthcare providers and facilities should stop using the affected kits and contact Orthofix for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
- 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 (3)
- Lot # B1201157
- B1203789
- B1226060
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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