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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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.
Recall Number Z-0417-2013
Classification Class II
Code Info Lot Numbers: 012064-001
Product Distributed Qty 19 units
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 past the disc space as this could result in the possible misplacement of the implant and/or possible harm to the patient."

Event Detail

Event Id 63075
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide including the states of: MA and TX.
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