Recall Z-0886-2017— Amendia, Inc

Name: FDA recall Z-0886-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-22

Class II · Terminated

Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2017-07-31. It names one FDA 510(k) clearance: K081770. 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. Reason: 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..

Recalling firm: Amendia, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Terminated: 2017-07-31
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K081770 — BLACK WIDOW ANTERIOR BUTTRESS PLATEOmni Surgical, L.P.·cleared 2009-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.