Recall Z-2984-2017 ยท MNI Orthosis, Spinal Pedicle Fixation
Valorem Surgical LLC
PALLAS M/MAXIMIS Open Extension (Small). 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.
| Date | Jun 21, 2017 |
| Status | Terminated |
| Reason | Devices are not consistent with Quality System Requirements. |
| Root cause | Device Design |
| Action | Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at global.safety@ValoremSurgical.com or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to global.safety@ValoremSurgical.com |
| Quantity | 262 units total |
| Distribution | Nationwide Distribution - US including CA and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM Valorem Surgical, Jan 7, 2015 |