Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS Polyaxial Screws and MIS Screws (5.5 x 40mm). These devices are part of the MAXIMIS Pedicle Screw Spinal Fixation System and are intended for posterior pedicle screw fixation of the non-cervical spine. The products were distributed nationwide in the United States, including California and Virginia.
The recall was initiated because the devices are not consistent with Quality System Requirements. The FDA has classified this as a Class II recall. The specific catalog number is P755-040, and known lot numbers include WNV110513, WNV120322, and WNV110511. The source text does not report any specific injuries or illnesses associated with these devices.
Healthcare providers and patients who have used these devices should contact Valorem Surgical LLC for further information and instructions on how to proceed.
The recalled product
- Product
- PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 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 s
- Manufacturer
- Valorem Surgical LLC
- Category
- Medical Device — Spinal Fixation
- Affected units
- 2,225
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog No. P755-040
- Known Lot No. Unknown
- WNV110513
- WNV120322
- WNV110511.
Distribution
Part of a larger recall action
This product is one of 144 recalled by Valorem Surgical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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