Orthofix Drill Bits Recalled for Geometrical Design Deviation
Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering 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 involves reduced performance rather than a direct safety risk like injury or infection, and no illnesses or injuries are reported in the source text.
Plain-English summary
Orthofix Srl is recalling specific lots of 4.8 mm drill bits (Catalogue Number ref 1100701) due to a geometrical detail that does not correspond to the intended design. The affected lots are B1200720, 289819, and 273352. These products are non-sterile and require a prescription.
The recall was initiated following complaint investigations that identified the design deviation. This issue could result in lower cutting performance. The products were distributed in numerous US states and territories, as well as in multiple countries including Kuwait, Australia, and the United Kingdom.
Healthcare providers and patients should stop using the affected drill bits and contact Orthofix Srl for further instructions or a replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
- 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 (3)
- Lot # B1200720
- 289819
- 273352
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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