Orthofix Galaxy Wrist Sterile Kit Drill Bits Recalled for Design Defect
Orthofix Srl is recalling Galaxy Wrist Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering 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. The hazard involves reduced cutting performance due to a design defect, which is a functional issue rather than a direct safety hazard like infection or injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Orthofix Srl is recalling the Galaxy Wrist Sterile Kit (Catalogue Number: 99-93601) due to a design defect in the drill bits. The recall was initiated after complaint investigations determined that the drill bits have a geometrical detail that does not correspond to the intended design.
This defect could result in lower cutting performance. The affected lots are 81213075, 81215044, 81216539, 81217847, and 81234691. The products were distributed in the United States (including Puerto Rico) and in numerous international locations.
Healthcare providers and consumers should stop using the affected drill bits and contact Orthofix Srl for further instructions on how to proceed with the recall.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
- 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 (5)
- Lot #: 81213075
- 81215044
- 81216539
- 81217847
- 81234691
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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