FDA Medical Device Recalls (openFDA)
Alphatec Spine, Inc.: Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
- Recall number
- Z-1819-2021
- Recalling firm
- Alphatec Spine, Inc.
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
- Status
- Terminated
- Initiated
- 2021-04-26
- Posted
- not on file
- Terminated
- 2022-11-17
- Reason
- There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
- 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: QMScompliance@atecspine.com 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
- 5 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.
- Lot, serial or model codes
- 8609325R
- 510(k) numbers
- ["K200995"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 2027467
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28