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.
Enforcement
- Recall Number
- Z-0417-2013
- Event ID
- 63075
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- SpineFrontier, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 28, 2012
- Initiation Date
- August 22, 2012
- Classification Date
- November 21, 2012
- Termination Date
- June 11, 2015
- Address
- 500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States
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.
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
Lot Numbers: 012064-001
US Nationwide including the states of: MA and TX.
19 units