Class II — Potential Health Hazard

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

T-Handle Recalled by SpineFrontier, Inc. Due to During an operation the strike plate of a...

Date: August 29, 2012
Company: SpineFrontier, Inc.
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 SpineFrontier, Inc. directly.

Affected Products

T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

Quantity: 11

Why Was This Recalled?

During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

Where Was This Sold?

This product was distributed to 3 states: MA, NV, TX

Affected (3 states)Not affected

About SpineFrontier, Inc.

SpineFrontier, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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