Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design
Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal 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
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 performance rather than a direct safety risk like infection or injury, with no reported adverse events.
Plain-English summary
Orthofix Srl is recalling specific lots of the Lower Limb Diaphyseal Sterile Kit (Catalogue Number: 99-93502). The recall affects kits with lot numbers B1200709, B1204115, B1206439, B1225414, and B1233729. These products were distributed in numerous US states, Puerto Rico, and various international locations.
Complaint investigations determined that the drill bits included in these batches have a geometrical detail that does not correspond to the intended design. This discrepancy could result in lower cutting performance. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should stop using the affected kits and contact Orthofix Srl for instructions on returning or replacing the product. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
- 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 (5)
- Lot # B1200709
- B1204115
- B1206439
- B1225414
- B1233729
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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