FDA Device recall Z-0417-2013
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implan…
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implan… by Spinefrontier, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0417-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-22 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
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
Identifiers
| code_info | Lot Numbers: 012064-001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2013%22
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