Amendia, Inc: Medical Device Recall in 2016 - (Recall #: Z-0887-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 28, 2016

Recall Number: Z-0887-2017

Event ID: 75869

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.

Status: Terminated

Product Quantity: 96 units

Code Information:

Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A

Distribution Pattern:

Nationwide Distribution to IN, LA, and TX

Voluntary or Mandated:

Voluntary: Firm initiated