Reported Sep 2, 2015 · Terminated
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex…
Trilliant Surgical Ltd.
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: Trilliant Surgical Ltd. · 6721 Portwest Dr Ste 160 · Houston, TX · 77024-8019
Is this the product you have?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Concave Reamer Head, 16 mm |
| 2 | Concave Reamer Head, 18 mm |
| 3 | Concave Reamer Head, 20 mm |
| 4 | Concave Reamer Head 22 mm |
| 5 | Convex Reamer Head, 16 mm |
| 6 | Convex Reamer Head, 18 mm |
| 7 | Convex Reamer Head 20 mm |
| 8 | Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones. |
- Lot codes and dates
TSL000145TSL000162TSL000699TSL000146TSL000163TSL000700TSL00147TSL000164TSL000701TSL000702TSL000148TSL000165TSL000706TSL000149TSL000166TSL000688TSL000150TSL000167TSL000707TSL000708
- Amount recalled
- 638 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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