Z-0417-2013 Class II Terminated
FDA device recall Z-0417-2013 was initiated by SpineFrontier, Inc. on Aug 22, 2012 and is designated Class II. 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 recall status is terminated (terminated Jun 11, 2015). Affected quantity: 19 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Aug 22, 2012
- Termination Date
- Jun 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
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
Distribution pattern
US Nationwide including the states of: MA and TX.
Code information
Lot Numbers: 012064-001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0417-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026