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 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, but the source text describes a performance defect (lower cutting performance) without reporting any injuries, hospitalizations, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary measures where significant harm is not reported.
Plain-English summary
Orthofix Srl is recalling specific lots of the Lower Limb Diaphyseal Sterile Kit (Sterile Gamma), catalog number 99-93502JP. The affected lots are B1202062, B1224660, B1227924, and B1231700. The product is a prescription-only medical device used for lower limb procedures.
The recall was initiated after complaint investigations determined that batches of drill bits included in the kits have a geometrical detail that does not correspond to the intended design. This deviation could result in lower cutting performance. The agency has classified this as a Class II recall.
The affected products were distributed in the United States (including Puerto Rico) and in numerous international locations, including Australia, Brazil, France, Germany, and Japan. Healthcare providers and patients who have used or possess these specific lots should contact Orthofix Srl for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
- 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 (4)
- Lot #: B1202062
- B1224660
- B1227924
- B1231700
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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