FDA-Device2016-12-28Class II
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 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
Amendia, Inc
Hazard
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.
Sold states
Nationwide Distribution to IN, LA, and TX
Affected count
48 units
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0886-2017Don't want to check this manually?
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