Reported Oct 29, 2014 · Terminated
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with…
Signal Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Signal Medical Corporation · 400 Pyramid Dr · Marysville, MI · 48040-2463
Is this the product you have?
- Symmetric Total
- Knee Femoral Components Product UsageSymmetric 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)
- Lot codes and dates
Catalog # 22-01-02106Lot # 1110Serial # L0259Size 6R Catalog #22-01-02106Lot # 2910Serial # L0533Size 6R Catalog # 22-01-02003Serial #s L0280L0283L0284L0285L0287L0288L0615Size 3 L Catalog # 22-01-02004Serial # l0358Size 4L Catalog # 22-01-02005Serial # L0809Size 5L Catalog #22-01-02006Serial #s L0692L0842L0485L0483L0486L0841L0844L0847Size 6L Catalog # 22-01-02007Serial #s L0721L0786L0787L0770L0772L0775Size 7L Catalog #22-01-02103Serial #s L0265L0272Size 3R Catalog # 22-01-02104Serial #s L0479L0515L0517Size 4R Catalog # 22/01-02106Serial # L0338L0508L0537L0853L0867L0872L0873Size 6R Catalog #22-01-02107Serial #s L0749L0758L0760L0755L0759L0762Size 7R
- Amount recalled
- 41
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MO
Why it was recalled
Packaging of a device was compromised
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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