Orthofix Radiolucent Wrist Fixator Kit Recalled for Drill Bit Design Defect
Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator 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 hazard involves reduced cutting performance without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthofix Srl is recalling specific lots of the Radiolucent Wrist Fixator Kit Complete System. The recall affects sterile, prescription-only kits distributed in the United States and several international markets.
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.
Healthcare providers and patients should stop using the affected kits and contact Orthofix Srl for further instructions. The affected lot numbers are B1200654, B1205554, B1208340, B1215045, B1215995, and B1232424.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
- 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 (6)
- Lot # B1200654
- B1205554
- B1208340
- B1215045
- B1215995
- B1232424
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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