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.
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, 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.
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