Class II — Potential Health Hazard

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

MEDLINE UNITE FOOT & ANKLE Screw Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to The recall is due to observed intra-operative screw...

Date: December 22, 2022
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
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 MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

Quantity: 420 units

Why Was This Recalled?

The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

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