CLASS II Device recall · Reported 16 Aug 2017 · FDA Enforcement Report
Pallas M/Maximis Dilator recalled by Valorem Surgical
Valorem Surgical is recalling Pallas M/Maximis Dilator A, distributed nationwide in the US. The recall was initiated on 21 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2979-2017
- FDA event ID
- 77500
- Recalling firm
- Valorem Surgical, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2017
- FDA classified
- 10 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 21 Jun 2017 | Recall initiated by company | |
| 10 Aug 2017 | Classified by FDA | +50 days |
| 16 Aug 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices are not consistent with Quality System Requirements.
Product as listed by the FDA
PALLAS M/MAXIMIS Dilator A. 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.
Where it was distributed
Nationwide Distribution - US including CA and VA.
Questions about this recall
Is Pallas M/Maximis Dilator A recalled?
Yes. Valorem Surgical recalled Pallas M/Maximis Dilator A on 21 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2979-2017.
Why was it recalled?
Devices are not consistent with Quality System Requirements.
Which lots are affected?
Catalog No. 0902-1003; Known Lot No. WNV111108, WNV120802, WNV111109.
Where was it sold?
Nationwide Distribution - US including CA and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valorem Surgical
All 144| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pallas M/Maximis Reduction recalled by Valorem Surgical | Valorem Surgical | Other | Nationwide |
| Device | CLASS II | Pallas M/Maximis Straight Rod recalled by Valorem Surgical | Valorem Surgical | Other | Nationwide |
| Device | CLASS II | Pallas M/maximis S recalled by Valorem Surgical | Valorem Surgical | Other | Nationwide |
| Device | CLASS II | Pallas M/Maximis Rod Pusher Angled recalled by Valorem Surgical | Valorem Surgical | Other | Nationwide |
| Device | CLASS II | Pallas M/Maximis Poly Screw 5 and mm screw recalled by Valorem Surgical | Valorem Surgical | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |