Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Black Widow 6.6mm x 20mm Screw Recalled by Amendia, Inc Due to There is a problem with the mating feature...

Date: November 22, 2016
Company: Amendia, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amendia, Inc directly.

Affected Products

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

Quantity: 96 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amendia, Inc

Amendia, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report