Class II — Potential Health Hazard

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

4.0mm x 10mm Cannulated Screw Recalled by Acumed LLC Due to Cannulated Screws 4.0mm x 10mm and 4.0mm x...

Date: March 9, 2022
Company: Acumed LLC
Status: Completed
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 Acumed LLC directly.

Affected Products

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

Quantity: 537 units

Why Was This Recalled?

Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Acumed LLC

Acumed LLC has 14 total recalls tracked by RecallDetector.

Related Recalls

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