Orthofix Drill Bits Recalled for Geometrical Design Deviation
Orthofix Srl is recalling specific lots of 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 hazard is limited to lower cutting performance without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific lots of Orthofix drill bits (Catalogue Number: ref 1-1300301, DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT). The affected products are identified by Lot # B1209082 and 273347. These items are prescription-only, non-sterile medical devices.
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. The agency has classified this as a Class II recall.
The products were distributed in the United States (AZ, CA, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, Puerto Rico) and internationally (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, Israel). Healthcare providers and patients should stop using these specific lots and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
- 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 (1)
- Lot # B1209082 and 273347
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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