Recall Z-1666-2013— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2013-05-07, terminated 2016-01-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for set screw to be come deformed..
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-07
- Terminated
- 2016-01-11
- Firm location
- Beverly, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.