Class II — Potential Health Hazard

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

CEMENT MIXING SYSTEM Recalled by BIOPSYBELL S.R.L. Due to Products labeled as sterile were distributed, but may...

Date: March 22, 2021
Company: BIOPSYBELL S.R.L.
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 BIOPSYBELL S.R.L. directly.

Affected Products

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

Quantity: 500 units

Why Was This Recalled?

Products labeled as sterile were distributed, but may not have been sterilized.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BIOPSYBELL S.R.L.

BIOPSYBELL S.R.L. has 19 total recalls tracked by RecallDetector.

Related Recalls

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