Orthofix Recalls Elbow Sterile Kits Due to Drill Bit Design Defect
Orthofix Srl is recalling specific lots of Elbow Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Orthofix Srl is recalling specific lots of the Elbow Sterile Kit (Catalogue Number: 99-93504) due to a manufacturing defect. The affected products are identified by the UDI (01)18054242511533 and include lot numbers B1203702, B1205553, B1209103, B1212944, B1215607, B1219056, and B1212544.
Complaint investigations determined that batches of 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. The recall is classified as FDA Class II.
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 should stop using the affected lots and contact Orthofix Srl for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
- Manufacturer
- Orthofix Srl
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 (7)
- Lot #: B1203702
- B1205553
- B1209103
- B1212944
- B1215607
- B1219056
- B1212544
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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