Z-1121-2017 Class II Terminated
FDA device recall Z-1121-2017 was initiated by Medtronic Neurosurgery on January 17, 2017 and is designated Class II. Reason for recall: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (… The recall status is terminated (terminated June 2, 2017). Affected quantity: 315,997.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- January 17, 2017
- Termination Date
- June 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315,997
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria