Small Bone Innovations Recalls Non-Sterile RingFIX Olive Wires
Small Bone Innovations is recalling non-sterile RingFIX Olive Wires because they were packaged with the wrong internal component.
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. The hazard is a packaging/labeling error (wrong component inside) without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling or packaging issues.
Plain-English summary
Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires. The specific items involved are labeled as item #451-3004, which are 1.8 mm diameter, 400mm olive k-wires with a drill tip.
The recall is due to a packaging error where these drill-tip wires were packaged with item #451-3005, which are 1.8mm diameter, 400mm olive k-wires with a bayonet tip, inside. The source text does not specify the number of affected units, the distribution scope, or any reported injuries or illnesses.
These devices are temporary medical instruments indicated for osteosynthesis of fractures, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
- Manufacturer
- Small Bone Innovations, Inc.
- Affected units
- 44
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 (2)
- item #451-3004
- lot V3R0R.
Distribution
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