Device product
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.
Z-1666-2013
Product summary
- Event
- Event 65442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 individual inserter assemblies
- Official record key
device-enforcement:Z-1666-2013
Official wording
Reason: Potential for set screw to be come deformed.
Code information: Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
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
Derived failure modes
-
Unknown
Potential for set screw to be come deformed.