Amendia, Inc recalls Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Butt…

Recall date

November 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0886-2017

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

Nationwide Distribution to IN, LA, and TX

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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