Recall Z-0417-2013— SpineFrontier, Inc.

Name: FDA recall Z-0417-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-22

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2012-08-22, terminated 2015-06-11. It names one FDA 510(k) clearance: K092815. Product: S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.. Reason: When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides.

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-22
Terminated: 2015-06-11
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K092815 — S-LIF INTERVERTEBRAL BODY FUSION DEVICESpinefrontier, Inc.·cleared 2010-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.

Reason for recall

When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides

Data sourced from openFDA. This site is unofficial and independent of the FDA.