Class II — Potential Health Hazard

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

PERLA TL Lateral Connector Open - Product Usage: intended to Recalled by SPINEART SA Due to Due to external labelling error/mix-up. Affected product external...

Date: April 9, 2021
Company: SPINEART SA
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 SPINEART SA directly.

Affected Products

PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

Quantity: 44 units in the U.S.

Why Was This Recalled?

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SPINEART SA

SPINEART SA has 13 total recalls tracked by RecallDetector.

Related Recalls

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