Reported Mar 29, 2017 · Terminated
Poly Component Trial, PS, 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, PS, packaged in the following sizes and configurations
12 of 12 products
| Model / number | Product as published |
|---|---|
90-SRK-180310 | Poly Component Trial - PS 3x10 |
90-SRK-180312 | Poly Component Trial - PS 3x12 |
90-SRK-180314 | Poly Component Trial - PS 3x14 |
90-SRK-180410 | Poly Component Trial - PS 4x10 |
90-SRK-180412 | Poly Component Trial - PS 4x12 |
90-SRK-180414 | Poly Component Trial - PS 4x14 |
90-SRK-180510 | Poly Component Trial - PS 5x10 |
90-SRK-180512 | Poly Component Trial - PS 5x12 |
90-SRK-180514 | Poly Component Trial - PS 5x14 |
90-SRK-180610 | Poly Component Trial - PS 6x10 |
90-SRK-180612 | Poly Component Trial - PS 6x12 |
90-SRK-180614 | Poly Component Trial - PS 6x14, The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint |
- Amount recalled
- 111 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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