Reported Mar 29, 2017 · Terminated
Poly Component Trial, MPCS, packaged in the following sizes and configurations
Medtronic Sofamor Danek USA Inc.
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: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
Poly Component Trial, MPCS, packaged in the following sizes and configurations
24 of 24 products
| Model / number | Product as published |
|---|---|
90-SRK-192310 | Poly Component Trial - MPCS 3x10L |
90-SRK-191310 | Poly Component Trial - MPCS 3x10R |
90-SRK-192312 | Poly Component Trial - MPCS 3x12L |
90-SRK-191312 | Poly Component Trial - MPCS 3x12R |
90-SRK-192314 | Poly Component Trial - MPCS 3x14L |
90-SRK-191314 | Poly Component Trial - MPCS 3x14R |
90-SRK-192410 | Poly Component Trial - MPCS 4x10L |
90-SRK-191410 | Poly Component Trial - MPCS 4x10R |
90-SRK-192412 | Poly Component Trial - MPCS 4x12L |
90-SRK-191412 | Poly Component Trial - MPCS 4x12R |
90-SRK-192414 | Poly Component Trial - MPCS 4x14L |
90-SRK-191414 | Poly Component Trial - MPCS 4x14R |
90-SRK-192510 | Poly Component Trial - MPCS 5x10L |
90-SRK-191510 | Poly Component Trial - MPCS 5x10R |
90-SRK-192512 | Poly Component Trial - MPCS 5x12L |
90-SRK-191512 | Poly Component Trial - MPCS 5x12R |
90-SRK-192514 | Poly Component Trial - MPCS 5x14L |
90-SRK-191514 | Poly Component Trial - MPCS 5x14R |
90-SRK-192610 | Poly Component Trial - MPCS 6x10L |
90-SRK-191610 | Poly Component Trial - MPCS 6x10R |
- Amount recalled
- 72 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
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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