Class II — Potential Health Hazard

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

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST Recalled by Nextremity Solutions Due to Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm...

Date: October 9, 2019
Company: Nextremity Solutions
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 Nextremity Solutions directly.

Affected Products

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.

Quantity: 49 units

Why Was This Recalled?

Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nextremity Solutions

Nextremity Solutions has 15 total recalls tracked by RecallDetector.

Related Recalls

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