Amendia, Inc recalls Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6m

Recalled December 28, 2016 · FDA recall Z-0887-2017 · 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

96 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 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

Manufacturer(s)

Amendia, Inc

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