Z-1666-2013 Class II Terminated
FDA device recall Z-1666-2013 was initiated by SpineFrontier, Inc. on May 7, 2013 and is designated Class II. Reason for recall: Potential for set screw to be come deformed. The recall status is terminated (terminated Jan 11, 2016). Affected quantity: 61 individual inserter assemblies.
Recall details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- May 7, 2013
- Termination Date
- Jan 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 individual inserter assemblies
Product description
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Reason for recall
Potential for set screw to be come deformed.
Distribution pattern
Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
Code information
Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1666-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026