Alphatec Spine, Inc. 1950 Camino Vida Roble Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
Brand
Alphatec Spine, Inc. 1950 Camino Vida Roble
Lot Codes / Batch Numbers
8609301R
Products Sold
8609301R
Alphatec Spine, Inc. 1950 Camino Vida Roble is recalling Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, due to There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026