Orthofix Drill Bits Recalled for Geometrical Design Defect
Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 indicates the hazard is limited to lower cutting performance without reports of injury, death, or serious adverse health consequences, fitting the criteria for a moderate severity rating.
Plain-English summary
Orthofix Srl is recalling specific batches of Orthofix drill bits (Catalogue Number: ref 1-1100301, Diameter 3.2 MM, Length 200 MM, Tin Coated, Quick Connect). The recall affects units with UDI (01)18033509856075 and specific lot numbers including B1203608, B1210965, B1211752, B1214172, B1218793, 300241, 300240, and 273169.
Complaint investigations determined that these batches have a geometrical detail that does not correspond to the intended design. This defect could result in lower cutting performance. The agency has classified this as a Class II recall.
The affected products were 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 (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 providers and patients should check their inventory or records for these specific lot numbers and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
- Manufacturer
- Orthofix Srl
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 (8)
- Lot # B1203608
- B1210965
- B1211752
- B1214172
- B1218793
- 300241
- 300240
- 273169
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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