Orthofix Drill Bits Recalled Due to Geometrical Design Defect
Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing 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. 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 lots of 8 mm diameter, 180 mm length, tin-coated quick-connect drill bits. 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 prescription-only and non-sterile. The recall includes specific lot numbers: B1200713, 289813, 300237, 300238, and 273342.
The product was distributed in numerous US states, including Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Puerto Rico. It was also distributed in several international locations, including Kuwait, Australia, Saudi Arabia, the United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, South Africa, Belgium, Chile, the Netherlands, Lithuania, Sri Lanka, Denmark, and Israel.
Healthcare providers and consumers should stop using the affected drill bits and contact Orthofix Srl for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
- 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 # B1200713
- 289813
- 300237
- 300238
- 273342
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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