CLASS II Device recall · Reported 16 Aug 2017 · FDA Enforcement Report

Pallas M/Maximis Straight Rod recalled by Valorem Surgical

Valorem Surgical is recalling Pallas M/Maximis Straight Rod, 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

Lot, batch or date codesCatalog No. SR60-400; Known Lot No. NHS160219.

Quantity recalled2,225 units total

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-2959-2017
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 400mm Straight Rod. 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.

Nationwide California Virginia

Questions about this recall

Why was it recalled?

Devices are not consistent with Quality System Requirements.

Which lots are affected?

Catalog No. SR60-400; Known Lot No. NHS160219.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 77500

This product is part of a recall event; the main page for the event is Pallas M/Maximis 350 Straight Rod recalled by Valorem Surgical.

Reported	Class	Recall	Company	Reason	Where
16 Aug 2017	CLASS II	Pallas M/Maximis 350 Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw5.5 recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Body Alignment Driver recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 6.5 and screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis 5.5 Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved and precontoured Rod recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Guide Wire recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Distractor recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Pedicle Cut recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/maximis C recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Miss/Mis Compressor and Rod Tightener recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Poly Screw Driver B recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Ratchet T Handle recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Dilator recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Pusher B recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Polyaxial and Mis Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved and Precontoured Rod recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Extension Guide Bush recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Tapper Part of Maximis Pedicle Screw recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Gauge recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Dilator Handle recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Holder recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Closed Extension recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 6.5 and screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 5.5 recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Wall Check recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Open Extension (Large) recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Polyaxial Screw and Mis Screw recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Instrument Tap recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Nut Inserter B recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Checker recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Marking Pin (Round Jaw) recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis 7.5 screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Open Extension (Small) recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Anti Torque recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis 5.5 Curved Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 5.5 and screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Tapper recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Driver Shaft (5Hex, Set Screw) Drive recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Small Crosslink recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 5.5 and screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Marking Pin (Smooth) recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Inside Bender (L) and (R) recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Torque Handle recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Checker and T-Bar recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Anti Torque Device recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Alignment Driver recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Miss/Mis Tapper Part of Maximis Pedicle recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Awl recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Cross Link Torque Handle recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Screw 6.5 and 6..5 screw recalled	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Dilator B recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Extension Block recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Set Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Poly Screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Rod Bender recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Compass recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017	CLASS II	Pallas M/Maximis Mis Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide

More recalls from Valorem Surgical

All 144

Reported	Class	Recall	Company	Reason	Where
16 Aug 2017Device	CLASS II	Pallas M/Maximis Reduction recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017Device	CLASS II	Pallas M/Maximis Straight Rod recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017Device	CLASS II	Pallas M/maximis S recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017Device	CLASS II	Pallas M/Maximis Rod Pusher Angled recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide
16 Aug 2017Device	CLASS II	Pallas M/Maximis Poly Screw 5.5 and screw recalled by Valorem Surgical	Valorem Surgical	Other	Nationwide

Other Spinal Implants recalls

All 1,157

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide