Orthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw
Orthofix Srl is recalling UE Xcaliber Ankle Complete Kits because drill bits have a design flaw 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, but the source text describes a performance issue (lower cutting performance) without reporting any injuries, illnesses, or structural failures that would meet the criteria for a Severe (4) rating.
Plain-English summary
Orthofix Srl is recalling specific batches of the UE Xcaliber Ankle Complete Kit (Catalogue Number: 99-91647UE). The recall involves kits with UDI (01)18032937169719 and specific lot numbers including B1206515, B1206561, B1209206, B1211406, B1212677, B1215964, and B1233839.
The recall was initiated after complaint investigations determined that the drill bits included in these kits have a geometrical detail that does not match the intended design. This deviation could result in lower cutting performance during use.
The affected products were distributed in the United States (including Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Puerto Rico) and in numerous international locations including Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, and Israel. Healthcare providers and patients should contact Orthofix Srl for further instructions on how to proceed.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
- Manufacturer
- Orthofix Srl
- Hazard
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 (7)
- Lot # B1206515
- B1206561
- B1209206
- B1211406
- B1212677
- B1215964
- B1233839
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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