Class II — Potential Health Hazard

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

Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an Recalled by Ebi, Llc Due to Several complaints were recorded regarding one of the...

Date: April 9, 2013
Company: Ebi, Llc
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 Ebi, Llc directly.

Affected Products

Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

Quantity: 1730 units

Why Was This Recalled?

Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ebi, Llc

Ebi, Llc has 9 total recalls tracked by RecallDetector.

Related Recalls

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