Z-2936-2017 Class II Terminated
FDA device recall Z-2936-2017 was initiated by Valorem Surgical LLC on June 21, 2017 and is designated Class II. Reason for recall: Devices are not consistent with Quality System Requirements. The recall status is terminated (terminated November 27, 2018). Affected quantity: 2,225 units total.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2017
- Initiation Date
- June 21, 2017
- Termination Date
- November 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,225 units total
Product Description
PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. 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.
Reason for Recall
Devices are not consistent with Quality System Requirements.
Distribution Pattern
Nationwide Distribution - US including CA and VA.
Code Information
Catalog No. PS365-040; Known Lot No. NHS150813, WNV101213.