Valorem Surgical LLC Recall: PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw.
Valorem Surgical LLC Recall: PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Valorem Surgical LLC; Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System.
| Recalling firm | Valorem Surgical LLC |
|---|---|
| Product | PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution - US including CA and VA. |
| Recall initiated | 20170621 |
| Recall number | Z-2927-2017 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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