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.
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, 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.
See all 31 products in this recall →Related recalls
Same manufacturer · Orthofix Srl
See all →- HighFitbone Trochanteric Nail may bend during insertion and require replacement
FDA (Devices) · 2025-06-25
- ModerateOrthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw
FDA (Devices) · 2019-11-20
- ModerateOrthofix Drill Bits Recalled for Geometrical Design Deviation
FDA (Devices) · 2019-11-20
Same hazard · performance defect
See all →- SevereBD Alaris Pump Infusion Sets Recalled for Performance Data Discrepancies
FDA (Devices) · 2026-09-23
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModeratePhilips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life
FDA (Devices) · 2025-07-09
- ModerateThermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
FDA (Devices) · 2025-06-18
Similar recalls
- SevereZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- ModerateZimmer GmbH Recalls AO Orthopedic Drills Due to Material Concerns
FDA (Devices) · 2019-05-29
- HighZimmer Biomet Recalls Orthopedic Drill Bits Due to Material Anomaly
FDA (Devices) · 2017-10-04
- HighZimmer GmbH Recalls 2.7mm Orthopedic Drills Due to Material Concerns
FDA (Devices) · 2019-05-29
- HighZimmer GmbH Recalls 19mm Orthopedic Drills Due to Material Concerns
FDA (Devices) · 2019-05-29
- HighZimmer GmbH Recalls 3.5mm Orthopedic Drill Due to Material Concerns
FDA (Devices) · 2019-05-29