Orthofix Drill Bits Recalled Due to Geometrical Design Deviation
Orthofix Srl is recalling specific batches of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering 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) rather than a direct safety hazard like injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific batches of drill bits (Catalogue Number: ref 1100201, 4.8 mm diameter, 240 mm length) due to a manufacturing defect. The recall was initiated after complaint investigations determined that the batches have a geometrical detail that does not correspond to the intended design.
This deviation could result in lower cutting performance. The affected product is non-sterile and prescription-only. The recall covers specific lot numbers: B1202045, B1206643, B1218524, 289818, and 273350.
The affected products were distributed in the United States (including Puerto Rico) and various international locations. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected drill bits. Consumers should not use these prescription-only medical devices and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
- 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 (5)
- Lot # B1202045
- B1206643
- B1218524
- 289818
- 273350
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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