Orthofix Drill Bits Recalled Due to Geometrical Design Deviation
Orthofix Srl is recalling specific lots of 4.8 mm 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 no illnesses or injuries have been reported, and the hazard is limited to lower cutting performance rather than direct physical harm.
Plain-English summary
Orthofix Srl is recalling specific lots of 4.8 mm drill bits (Catalogue Number: ref 1100101) because complaint investigations revealed that a geometrical detail does not correspond to the intended design. This deviation could result in lower cutting performance. The affected lots are B1208414, B1218188, 289817, and 273349.
The recall covers products distributed in the United States (including Puerto Rico) and numerous international locations. The products are non-sterile and require a prescription (RX ONLY). No illnesses or injuries have been reported in the source text.
Healthcare providers and patients should stop using the affected drill bits and contact Orthofix Srl for further instructions or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
- 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 (4)
- Lot # B1208414
- B1218188
- 289817
- 273349
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 →- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
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
- ModerateID NOW COVID-19 2.0 Point-of-Care Test Device Recall
FDA (Devices) · 2025-04-23