Orthofix Ankle Transfix Pin Sterile Kit Recalled for Design Defect
Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce 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 describes a performance defect (lower cutting performance) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific batches of the Ankle Transfix Pin Sterile Kit (Catalogue Number: 99-93503US). The recall affects lots B1200695 and B1224714. The product is a sterile medical device kit used for orthopedic procedures.
The recall was initiated after complaint investigations determined that the drill bits included in the kits have a geometrical detail that does not correspond to the intended design. This defect 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. Healthcare providers and facilities should stop using the affected lots and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
- 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 (2)
- Lot #: B1200695
- B1224714
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
- SevereOrthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighExactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighExactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- HighCorin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- HighZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04