CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

Atec Insignia Anterior Cervical Plate System recalled by Alphatec Spine

Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System, distributed nationwide in the US. The recall was initiated on 26 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes8609324R

Quantity recalled7 units

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-1818-2021
FDA event ID: 87887
Recalling firm: Alphatec Spine, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 26 Apr 2021
FDA classified: 7 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

26 Apr 2021	Recall initiated by company
7 Jun 2021	Classified by FDA	+42 days
16 Jun 2021	Published in enforcement report	+9 days

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

Reason for recall

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583

Where it was distributed

US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.

Nationwide California Connecticut Florida Hawaii Idaho Illinois Indiana Massachusetts North Carolina New Mexico New York Oklahoma South Carolina Texas Washington

Questions about this recall

Is Atec Insignia Anterior Cervical Plate System recalled?

Yes. Alphatec Spine recalled Atec Insignia Anterior Cervical Plate System on 26 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1818-2021.

Why was it recalled?

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Which lots are affected?

8609324R

Where was it sold?

US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.

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 Alphatec Spine

All 46

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	SafeOp Patient Interface recalled by Alphatec Spine	Alphatec Spine	Device Malfunction	Nationwide
18 Feb 2026Device	CLASS II	Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome recalled	Alphatec Spine	Sterility	Nationwide
18 Feb 2026Device	CLASS II	Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome recalled	Alphatec Spine	Sterility	Nationwide
5 Feb 2025Device	CLASS II	Calibrate CCX Interbody System for spinal fusion procedures recalled	Alphatec Spine	Sterility	Nationwide
6 Mar 2024Device	CLASS II	IdentiTi ALIF Standalone Interbody System recalled by Alphatec Spine	Alphatec Spine	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide