Orthofix Drill Bits Recalled for Geometrical Design Defect
Orthofix Srl is recalling specific batches of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower 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 breakage or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Orthofix Srl is recalling specific batches of 2.7 mm drill bits (Catalogue Number: ref 1355001) due to a geometrical defect. The affected product is a non-sterile, prescription-only medical device with a length of 127 mm.
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 recall involves lot numbers B1215075, 303106, 289822, and 273357.
The affected units were distributed in various US states and internationally. Consumers and healthcare providers should stop using these specific drill bits and contact the manufacturer for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
- 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 # B1215075
- 303106
- 289822
- 273357
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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