Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect
Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical 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 specific lots of the Prefix II Ankle Complete Kit (Catalogue Number: 99-92504). The recall was initiated after complaint investigations determined that batches of 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 lots are B1207288, B1215312, B1228971, and B1233730. The products were distributed in the United States and various international locations, including Kuwait, Australia, and the United Arab Emirates.
Healthcare providers and consumers should stop using the affected kits and contact Orthofix Srl for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
- 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 (4)
- Lot # B1207288
- B1215312
- B1228971
- B1233730 *Not marketed in US
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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