Class II — Potential Health Hazard

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

ACETABULAR FIXATION CUP Recalled by Synovo Production Due to Medical device components were marketed without FDA clearance...

Date: May 30, 2023
Company: Synovo Production
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 Synovo Production directly.

Affected Products

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

Quantity: 764 units

Why Was This Recalled?

Medical device components were marketed without FDA clearance and without FDA approval

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Synovo Production

Synovo Production has 3 total recalls tracked by RecallDetector.

Related Recalls

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