Orthofix Drill Bits Recalled for Geometric Design Deviation
Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometric 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, and the source text identifies a performance defect (lower cutting performance) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Orthofix Srl is recalling specific lots of Orthofix drill bits (Catalogue Number: ref 1-1100701, 4.8 mm diameter, 280 mm length, tin-coated, quick connect). The affected lots are B1199835, 289815, and 273344. These medical devices are prescription-only and non-sterile.
The recall was initiated after complaint investigations determined that the batches have a geometrical detail that does not correspond to the intended design. This deviation could result in lower cutting performance during use.
The affected products were distributed in the United 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) and in numerous countries outside the US, including Kuwait, Australia, Saudi Arabia, 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. Users should stop using the affected drill bits and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
- 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 # B1199835
- 289815
- 273344
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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