Straumann recalls GM Helix Acqua Implant (Article 140.984) due to possible 11.5mm vs 13mm implant mix-up in packaging. Affected units may cause improper fit if used in dental procedures.
“Straumann GM Helix Acqua Implant Recall: 11.5mm vs 13mm implant mix-up.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52361-straumann-gm-helix-acqua-implant-recall-11-5mm-vs-13mm. Based on FDA recall #Z-1862-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1862-2025%22&limit=1).
Straumann USA LLC recalled GM Helix Acqua Implants with Article Number 140.984 due to a labeling error where an 11.5 mm implant may be packaged as a 13 mm unit, the FDA said on May 1, 2025.
How to tell if you have it
Brand: Straumann
Product: GM Helix Acqua Implant
Article Number: 140.984
Lot number: JPZ21
The hazard
The hazard is that a package labeled as an 11.5 mm implant may contain a 13 mm implant instead, according to the FDA.
Context
GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Other recent recalls of similar products include EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026), Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall (March 20, 2026), and Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE: Packaging Mix-Up Recall (Feb. 16, 2026).
How to tell if you have this one
Check for the product name 'GM Helix Acqua Implant' and Article Number 140.984. Look for the UDI-DI code (01)7899878025290(11)220122(17)260121(10)JPZ21 and Lot number JPZ21 on the packaging.
Brand
Straumann
Category
Medical device
FDA recall event · 2 products
All 2 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
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.
Verify the Article Number and UDI-DI code on the packaging to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, Wisconsin.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1862-2025 (May 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1862-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.