Agency classClass IIOur severity:Severe FDA (Devices)·Z-0887-2017·Announced 2016-12-28

Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or structural defects in medical devices are classified as Severe (Score 4).

Plain-English summary

Amendia, Inc. is recalling 96 units of Black Widow 6.6mm x 20mm, 25mm, and 30mm screws. These medical devices are designed to prevent the migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. The recall covers specific lot numbers for part numbers TBS020, TBS025, and TBS030.

The recall was initiated because there is a problem with the mating feature between the plate and the screw. This defect could cause the plate opening not to interfere enough with the plate and the head of the screw. The agency has classified this recall as Class II.

The affected units were distributed nationwide to Indiana, Louisiana, and Texas. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.

The recalled product

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…
Manufacturer: Amendia, Inc
Category: Medical Device — Orthopedic / Spinal
Hazard: structural-defect
device-failure
Affected units: 96

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Amendia, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Amendia, Inc

See all →

Moderate
Amendia Recalls Mac Pin Non-Cannulated Screws Due to Incorrect Length Labeling
FDA (Devices) · 2018-01-17
High
Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking
FDA (Devices) · 2018-01-10
Moderate
Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery
FDA (Devices) · 2017-05-03
High
Amendia Recalls Ceres-C Cervical Interbody Devices Due to Missing Pin
FDA (Devices) · 2017-01-18
Moderate
Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28

Same hazard · structural defect