Orthofix Drill Bits Recalled for Geometrical Design Deviation
Orthofix Srl is recalling specific lots of non-sterile 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 explicitly states the issue results in lower cutting performance without reporting injuries, deaths, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific lots of non-sterile drill bits (Catalogue Number: ref 1-1100201, Diameter .4,8 MM, L.240 MM, TIN Coated - Quick Connect) due to a design deviation. The affected products are prescription-only medical devices.
The recall was initiated after complaint investigations determined that batches of the drill bits have a geometrical detail that does not correspond to the intended design. This deviation could result in lower cutting performance. The agency has classified this as a Class II recall.
The affected lots are B1205238, B1205760, B1213842, 289814, 300239, 289814, and 273343. The products were distributed in the United States (including Puerto Rico) and various international locations. Healthcare providers and patients should stop using these specific lots and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
- 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 (6)
- Lot # B1205238
- B1205760
- B1213842
- 289814
- 300239
- 273343
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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