Reported Dec 28, 2016 · Terminated
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow…
Amendia, 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: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
TBS020 | Black Widow 6.6mm x 20mm Screw |
TBS025 | Black Widow 6.6mm x 25mm Screw |
TBS030 | Black Widow 6.6mm x 30mm Screw, The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region |
- Amount recalled
- 96 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
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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