Orthofix Recalls Prefix II Diaphyseal Complete Kit Due to Drill Bit Design
Orthofix Srl is recalling the Prefix II Diaphyseal Complete Kit 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 defect (lower cutting performance) rather than a direct safety hazard like infection or injury, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Orthofix Srl is recalling the Prefix II Diaphyseal Complete Kit (Catalogue Number: ref: 99-92503) due to a manufacturing defect. The recall was initiated after complaint investigations revealed that batches of drill bits included in the kit have a geometrical detail that does not correspond to the intended design.
This design discrepancy could result in lower cutting performance during use. The affected lot is identified as Lot # B1207287. The source text notes that this specific lot was not marketed in the US, although the distribution pattern lists various US states and international locations for the product line.
Healthcare providers and facilities should stop using the affected drill bits and contact Orthofix Srl for further instructions on the recall.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
- 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 (1)
- Lot # B1207287 *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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