Recall Z-1666-2013
SpineFrontier, Inc. · initiated May 7, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
Reason for recall
Potential for set screw to be come deformed.
FDA-determined cause: Device Design
Action taken
Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990.
Details
- Recall number
- Z-1666-2013
- Initiated
- May 7, 2013
- Posted by FDA
- July 5, 2013
- Terminated
- January 11, 2016
- Product code
- HXX – Screwdriver
- Quantity
- 61 individual inserter assemblies
- Distribution
- 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
- Recalling firm
- SpineFrontier, Inc., Beverly, MA