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

Recalled December 28, 2016 · FDA recall Z-0886-2017 · Amendia

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. · FDA Class II

Units

48 units

Sold at

Nationwide Distribution to IN, LA, and TX

Description

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.

Product

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

Manufacturer(s)

Amendia, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →