Class II — Potential Health Hazard

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

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used Recalled by INCIPIO DEVICES Due to Recalled lot does not meet specification and has...

Date: October 30, 2024
Company: INCIPIO DEVICES
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 INCIPIO DEVICES directly.

Affected Products

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

Quantity: 100 units

Why Was This Recalled?

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About INCIPIO DEVICES

INCIPIO DEVICES has 1 total recall tracked by RecallDetector.

Related Recalls

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