Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 Gui

U.S. FDA — Device Enforcement · United States · 2012-08-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0417-2013
Date of alert: 2012-08-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: SpineFrontier, Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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