Neoc: Gen 2 Posterior Chairside Splint LRUL Mislabeled - Recall
Neocis recalls Gen 2 Posterior Chairside Splint LRUL due to possible mislabeling. Affected units may not be correctly labeled for dental implant surgery use.
Lower-risk recall
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Contact the company
What happened, in plain English
Neocis is recalling its Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) because it may be mislabeled. This could lead to incorrect use during dental implant surgery. Consumers should check their product's work order numbers to see if it's affected. Read more at govinfonow.com/recall/65153-neoc-gen-2-posterior-chairside-splint-lrul-mislabeled-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/65153-neoc-gen-2-posterior-chairside-splint-lrul-mislabeled-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2638-2020
Cite this page
“Neoc: Gen 2 Posterior Chairside Splint LRUL Mislabeled - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65153-neoc-gen-2-posterior-chairside-splint-lrul-mislabeled-recall. Based on FDA recall #Z-2638-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2638-2020%22&limit=1).
Why it’s dangerous
The splints may be mislabeled, meaning they might not be correctly identified for dental implant surgery use. This could lead to incorrect application during procedures. However, the recall does not indicate a risk of injury or serious harm.
Who’s affected
Dental professionals who use Neocis Gen 2 Posterior Chairside Splints may be affected. Those with work order numbers 1616, 1621, or 1622 are most at risk.
How to tell if you have this one
Check the work order number on the splint. Affected units have work order numbers 1616, 1621, or 1622. The product is used for dental implant surgery planning and procedures.
- Brand
Neocis- Category
Medical device
All 3 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 including in the states of AZ, CA, FL, NY, and NH
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2637-2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.; Work Order (lot): 1619 and 1620 | 70 units |
| Z-2638-2020 | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.; Work Order (lot): 1616, 1621, and 1622 | 70 units |
| Z-2639-2020 | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.; Work Order (lot): 1623 | 50 units |
What to do — step by step
Check Product Label
Look for the work order number on the splint. Affected units have work order numbers 1616, 1621, or 1622.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, New Hampshire, New York.
Recall timeline
FDA terminated this recall 14 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-2638-2020 (May 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2638-2020 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.