Device product
PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Z-2982-2017
Product summary
- Event
- Event 77500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 262 units total
- Official record key
device-enforcement:Z-2982-2017
Official wording
Reason: Devices are not consistent with Quality System Requirements.
Code information: Catalog No. 0902-1007; Known Lot No. WNV120817, NHS170405.
Distribution pattern: Nationwide Distribution - US including CA and VA.
Derived failure modes
-
Unknown
Devices are not consistent with Quality System Requirements.