Lower risk Medical device recall · FDA · Published July 13, 2026

Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk

Straumann recalls GM Helix dental implants with possible packaging mismatch. Incorrect implants could cause bone compression during installation if bone volume is sufficient.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2929-2026Medical device Straumann ›

Lower-risk recall

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

✎ GovInfoNow plain-language explainer

Straumann is recalling GM Helix dental implants that may have a mismatch between the implant inside packaging and the label. This could lead to bone compression or installation difficulties if there's enough bone volume. Read more at govinfonow.com/recall/459409-straumann-gm-helix-dental-implant-recall-packaging-mismatch-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/459409-straumann-gm-helix-dental-implant-recall-packaging-mismatch-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2929-2026

Cite this page

“Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459409-straumann-gm-helix-dental-implant-recall-packaging-mismatch-risk. Based on FDA recall #Z-2929-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2929-2026%22&limit=1).

Straumann USA LLC recalled GM Helix Implant, Endosseous Dental Implant Article No. 109.984 due to a potential mismatch between the implant and its packaging label, which could cause bone compression or installation difficulty. The Food and Drug Administration announced the voluntary Class II recall on July 13, 2026.

How to tell if you have it

Brand: Straumann
Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
UDI-DI: 7899878024552
Lot: MVXJ9
Quantity: 417 units in the US

The hazard

The recall addresses a mismatch between the implant inside the packaging and the information on the outer carton label. If an incorrect implant is installed, it could cause bone compression or difficulty during installation where sufficient bone volume exists.

Context

GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Recent similar recalls include the August 12, 2026 GM Helix Implant packaging mismatch and the July 16, 2026 Bone Level Tapered Implant length discrepancy. Other recent recalls of similar products include the January 5, 2026 Encore Medical EMPOWR 3D Knee Tibial Insert Packaging Discrepancy Risk, the February 16, 2026 Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE Packaging Mix-Up Recall, and the April 3, 2026 Depuy ATTUNE Revision Hinge Femoral LT SZ 8 CEM Sterility Packaging Risk.

How to tell if you have this one

Check for the product code 'Article No. 109.984' on the packaging. The recall applies to implants sold with UDI-DI 7899878024552 lot number MVXJ9.

Brand
Straumann
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging Details
Verify the implant code on the packaging matches the product code 'Article No. 109.984' and lot number 'MVXJ9'.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 35 states.

FDA distribution: “US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nevada, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 37 days after the firm started it.

Jul 13, 2026Firm started the recall
Aug 10, 2026FDA classified it Class II
Aug 19, 2026Published in FDA’s Enforcement Report
Aug 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the implant?

No action is required if the implant matches the packaging. The recall only applies to potential mismatches, not current implants.

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Link to this recall

<a href="https://govinfonow.com/recall/459409-straumann-gm-helix-dental-implant-recall-packaging-mismatch-risk">Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (GovInfoNow)</a>

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-2929-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2929-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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.