Alphatec Insignia Anterior Cervical Plate System Recall: Screw Mechanism Risk
Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0354) due to potential screw mechanism disassociation post-surgery. Affected patients should contact the company for details.
Recall notice
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Contact the company
What happened, in plain English
Alphatec is recalling its Insignia Anterior Cervical Plate System (3-level, 54mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts during healing. Read more at govinfonow.com/recall/62700-alphatec-insignia-anterior-cervical-plate-system-recall-screw-mechanism-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62700-alphatec-insignia-anterior-cervical-plate-system-recall-screw-mechanism-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1818-2021
Cite this page
“Alphatec Insignia Anterior Cervical Plate System Recall: Screw Mechanism Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62700-alphatec-insignia-anterior-cervical-plate-system-recall-screw-mechanism-risk. Based on FDA recall #Z-1818-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2021%22&limit=1).
Why it’s dangerous
The screw blocking mechanism in the anterior cervical plate system might disassociate or unlock after surgery. This could cause the plate to shift, potentially leading to complications in spinal healing.
Who’s affected
Patients who received this spinal implant during surgery are most at risk. The recall applies to specific models sold with a unique identifier.
How to tell if you have this one
Check for the model number 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile. The unique identifier (UDI) is (01)00190376268583 or 8609324R.
- Brand
Alphatec- Product
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI- Category
Medical device
All 29 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1799-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422; 8609301R | 8 units |
| Z-1800-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439; 8663405R and 8800402 | 6 units |
| Z-1801-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446; 8609303R and 8800403 | 7 units |
| Z-1802-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453; 8609304R | 13 units |
| Z-1803-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460; 8609305R | 10 units |
| Z-1804-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477; 8609306R | 7 units |
| Z-1805-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484; 8609307R | 8 units |
| Z-1806-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743; 8609309R | 8 units |
| Z-1807-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361; 8609312R | 3 units |
| Z-1808-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378; 8609313R and 8800410 | 6 units |
| Z-1809-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385; 8609314R | 18 units |
| Z-1810-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392; 8609315R | 19 units |
| Z-1811-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408; 8663401R, 8609316R | 26 units |
| Z-1812-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415; 8663402R and 8609317R | 14 units |
| Z-1813-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507; 8663403R & 8609318R | 3 units |
| Z-1814-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521; 8609319R and 8663404R | 3 units |
| Z-1815-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538; 8663405R | 1 unit |
| Z-1816-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569; 8609322R | N/A |
| Z-1817-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576; 8609323R | 4 units |
| Z-1818-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583; 8609324R | 7 units |
| Z-1819-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590; 8609325R | 5 units |
| Z-1820-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606; 8609326R | 3 units |
| Z-1821-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613; 8609327R | 1 units |
| Z-1822-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620; 8609328R | 7 units |
| Z-1823-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637; 8609329R | 1 units |
| Z-1824-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675; 8609331R | 2 units |
| Z-1825-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699; 8609333R | 5 units |
| Z-1826-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705; 8609334R | 1 unit |
| Z-1827-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712; 8609335R | 1 unit |
What to do — step by step
Contact Manufacturer
Reach out to Alphatec Spine, Inc. for specific instructions on the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
FDA distribution: “US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Massachusetts, New Mexico, New York, North Carolina, Oklahoma, South Carolina, Texas, Washington.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1818-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1818-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.