Z-1817-2021Class II

Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only...

Name: Z-1817-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only...
Creator: Alphatec Spine, Inc.
Published: 2021-04-26
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2021-04-26 / Terminated

FDA source

Alphatec Spine, Inc. began a recall of Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576 on 2021-04-26. FDA classified it as Class II and gives the reason as "There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1817-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Posted: 2021-06-07
Terminated: 2022-11-17
Recalling firm: Alphatec Spine, Inc.
Product: Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
FDA root cause: Under Investigation by firm
Action: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: [email protected] 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
Product codes and lots: 8609323R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1817-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1799-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1800-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1801-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1802-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1803-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1804-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1805-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1806-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1807-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1808-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1809-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1810-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1811-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1812-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1813-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1814-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1815-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1816-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1817-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1818-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1819-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1820-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1821-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1822-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1823-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1824-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1825-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1826-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1827-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07

Product code KWQ

K200995Class IIInsignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. / cleared 2020-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)