Signal Medical Recalls Total Knee Femoral Components Due to Packaging Compromise
Signal Medical Corporation is recalling 41 Symmetric Total Knee Femoral Components because their packaging was compromised. The components were distributed in Missouri and Panama.
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 compromised packaging, which is a potential risk but does not involve reported injuries or high-risk pathogens, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Signal Medical Corporation is recalling 41 units of Symmetric Total Knee Femoral Components. These medical devices are intended for use with the Signal Medical Corp. Total Knee System for cemented use in Total Knee Replacement procedures. The femoral components are made of cobalt chromium alloy (ASTM F75).
The recall was initiated because the packaging of the devices was compromised. The affected units were distributed nationwide in the United States, specifically in the state of Missouri, and internationally to Panama.
Consumers and healthcare providers who have these specific components should stop using them and contact Signal Medical Corporation for instructions on how to return or replace the devices.
The recalled product
- Product
- Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
- Manufacturer
- Signal Medical Corporation
- Hazard
- Affected units
- 41
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 (20)
- Catalog # 22-01-02106
- Lot # 1110
- Serial # L0259
- Size 6R Catalog #22-01-02106
- Lot # 2910
- Serial # L0533
- Size 6R Catalog # 22-01-02003
- Serial #s L0280
- L0283
- L0284
- L0285
- L0287
- L0288
- L0615
- Size 3 L Catalog # 22-01-02004
- Serial # l0358
- Size 4L Catalog # 22-01-02005
- Serial # L0809
- Size 5L Catalog #22-01-02006
- Serial #s L0692
Distribution
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