Orthofix Drill Bits Recalled for Geometrical Design Deviation
Orthofix Srl is recalling specific 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 hazard is 'lower cutting performance' with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthofix Srl is recalling Orthofix drill bits (Catalogue Number: ref 11007, 4.8 MM diameter, 280 MM length) due to a geometrical detail that does not correspond to the intended design. The affected product is identified by Lot # B1200908 and UDI (01)18032568031959.
The recall was initiated following complaint investigations that determined the design deviation could result in lower cutting performance. The agency has classified this as a Class II recall.
The product was distributed in the United States (including 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, and Puerto Rico) and internationally in countries 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. Healthcare professionals 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 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
- 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 # B1200908
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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