CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Vital Mis Spinal Fixation system implants Cann Poly Ext Tab 5X45MM recalled

Zimmer Biomet is recalling Vital Mis Spinal Fixation system implants Cann Poly Ext Tab 5X45MM, distributed nationwide in the US. The recall was initiated on 5 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160

Quantity recalled3235 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-2225-2020
FDA event ID: 85613
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2020
FDA classified: 2 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

5 May 2020	Recall initiated by company
2 Jun 2020	Classified by FDA	+28 days
10 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Product as listed by the FDA

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Where it was distributed

US nationwide distribution.

Nationwide

Stores named: Walmart

Questions about this recall

Is Vital Mis Spinal Fixation system implants Cann Poly Ext Tab 5X45MM recalled?

Yes. Zimmer Biomet recalled Vital Mis Spinal Fixation system implants Cann Poly Ext Tab 5X45MM on 5 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2225-2020.

Why was it recalled?

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Which lots are affected?

UDI: (01)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160

Where was it sold?

US nationwide distribution.

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 Zimmer Biomet

All 873

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30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5 Spinal System and Polaris 5/Cypher Spinal System recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	Nationwide

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9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide