Orthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect
Orthofix Srl is recalling UE Xcaliber Metadiaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.
What this means for you
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 involves reduced performance rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity rating.
Plain-English summary
Orthofix Srl is recalling the UE Xcaliber Metadiaphyseal Complete Kit (Catalogue Number: 99-91600UE) in the United States and several international markets. The recall involves specific lots of the product, including B1207402, B1209817, B1211407, B1212676, B1229618, B1232423, B1233324, and B1233663.
The recall was initiated after complaint investigations determined that batches of drill bits included in the kits have a geometrical detail that does not correspond to the intended design. This defect could result in lower cutting performance. The agency has classified this as a Class II recall.
Healthcare providers and patients who have used or possess these specific kits should contact Orthofix Srl for further instructions on how to proceed. The product is distributed in numerous US states and internationally, including in Kuwait, Australia, and the United Arab Emirates.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
- 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 (8)
- Lot # B1207402
- B1209817
- B1211407
- B1212676
- B1229618
- B1232423
- B1233324
- B1233663
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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