Orthofix Drill Bits Recalled Due to Geometric Design Defect
Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric 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. 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 3.2 mm drill bits (Catalogue Number ref 1100301) 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 defect could result in lower cutting performance. The affected product is a non-sterile, prescription-only medical device. The recall covers specific lot numbers: B1202045, B1206643, B1218524, and 273351.
The product was distributed in numerous US states and territories, as well as in multiple international countries. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected drill bits. No specific instructions for consumer action are provided in the source text, as the product is prescription-only.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
- 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 # B1202045
- B1206643
- B1218524
- 273351
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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