Reported Aug 16, 2017 · Terminated
PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,…
Valorem Surgical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valorem Surgical LLC · 3963 W Belmont Ave Ste 9 · Chicago, IL · 60618-5129
Is this the product you have?
- PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. 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.
- Lot codes and dates
Catalog No. P765-035Known Lot No. WNV110513WNV120420
- Amount recalled
- 2,225 units total
This recall covers 144 products
The agency filed one notice per product. You are reading one of them; the other 143 are below.
131 more are in the archive.
Where it was sold
Why it was recalled
Devices are not consistent with Quality System Requirements.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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