Orthofix Drill Bits Recalled Due to Geometrical Design Defect
Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially reducing 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 source text describes a performance defect (lower cutting performance) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific lots of Orthofix drill bits (Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT). The recall affects units with Lot numbers 300244, 300243, 289816, and 273348. These products were distributed in numerous US states and internationally.
The recall was initiated following complaint investigations that determined the affected batches have a geometrical detail that does not correspond to the intended design. This defect could result in lower cutting performance.
Healthcare providers and facilities should stop using the affected drill bits and contact Orthofix Srl for further instructions on the recall process.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
- 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 # 300244
- 300243
- 289816
- 273348
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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