Reported Mar 20, 2019 · Terminated
Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt…
Ossur Americas
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: Ossur Americas · 27051 Towne Centre Dr · Foothill Ranch, CA · 92610-2804
Is this the product you have?
4 of 4 products · 4 lot codes
| Part | Description |
|---|---|
545700K |
|
545700L |
|
545800K |
|
545800L |
|
- Lot codes and dates
- All lots of the products manufactured from 06/30/2009 - 12/13/2018
- Amount recalled
- 381
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
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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