Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect
Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the 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 identifies a performance defect (lower cutting performance) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Orthofix Srl is recalling specific lots of the Ankle Sterile Kit (Catalogue Number: ref:99-93503, UDI: (01)18033509859922). The affected lots are B1200695 and B1224714. This recall was initiated by the U.S. Food and Drug Administration under recall number Z-0400-2020.
Complaint investigations revealed that the drill bits included in these 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 U.S., 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:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
- 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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