Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect
Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical 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. The hazard is a performance defect (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 lots of the Prefix II Diaphyseal Complete Kit (Catalogue Number: 99-92501). The recall involves sterile short screws and associated drill bits. The affected lots are B1207286, B1207428, B1211384, and B1215263.
The recall was initiated after complaint investigations determined that the drill bits in these batches have a geometrical detail that does not match the intended design. This defect could result in lower cutting performance during use.
The 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 countries outside the US. Healthcare providers and patients should contact Orthofix Srl for further instructions on how to handle the affected devices.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
- 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 (4)
- Lot # B1207286
- B1207428
- B1211384
- B1215263 *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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