Z-1565-2014 Class II Terminated
FDA device recall Z-1565-2014 was initiated by SpineFrontier, Inc. on Dec 23, 2011 and is designated Class II. Reason for recall: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the… The recall status is terminated (terminated May 20, 2014). Affected quantity: 30 devices.
Recall details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- Dec 23, 2011
- Termination Date
- May 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 devices
Product description
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Reason for recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Distribution pattern
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Code information
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1565-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026