Blue Belt Technologies Recalls Mislabeled Stride Femoral Knee Components
Blue Belt Technologies is recalling two lots of Stride Femoral Knee Components due to packaging mislabeling that could lead to the implantation of the wrong side or size.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a labeling error that could lead to the implantation of the wrong device, which is a significant risk but does not involve a direct toxic or structural defect in the device itself.
Plain-English summary
Blue Belt Technologies is voluntarily recalling two specific lots of Stride Femoral Components, a type of unicondylar knee prosthesis. The recall is due to a labeling error where the physical implants inside the packages do not match the labels on the outside.
Specifically, packages labeled as PFSI-00053 (Right Lateral/Left Medial) contain PFSI-00054 (Right Medial/Left Lateral) implants. Conversely, packages labeled as PFSI-00054 (Stride Right Medial/Left Lateral) contain PFSI-00053 (Left Medial/Right Lateral) implants. This discrepancy creates a risk that a surgeon might implant the wrong component during a knee replacement procedure.
The affected products are Lot C785241, with an expiration date of 4-2015. The products were distributed nationwide in California, Pennsylvania, and Texas. Healthcare providers and patients should check their inventory and records for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
- Manufacturer
- Blue Belt Technologies MN
- Affected units
- 2
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)
- Lot C785241
- Exp 4-2015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Blue Belt Technologies MN 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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