Z-0877-2015 Class II Terminated
FDA device recall Z-0877-2015 was initiated by PEROUSE MEDICAL on October 6, 2014 and is designated Class II. Reason for recall: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure The recall status is terminated (terminated March 24, 2017). Affected quantity: 2184 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2015
- Initiation Date
- October 6, 2014
- Termination Date
- March 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2184 units
Product Description
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
Reason for Recall
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Distribution Pattern
US Nationwide Distribution in the states of AZ and CO.
Code Information
Batch numbers: 4041354/4062650/4072586