Class II — Potential Health Hazard

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

40 mm Rod Recalled by Spinal Solutions, LLC Due to The recall of the Loaner Bin and Sterilization...

Date: February 20, 2013
Company: Spinal Solutions, 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 Spinal Solutions, LLC directly.

Affected Products

40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

Quantity: 63 units

Why Was This Recalled?

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Spinal Solutions, LLC

Spinal Solutions, LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

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