FDA-Device2016-12-28Class II
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 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
96 units
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 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-0887-2017Don't want to check this manually?
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