Straumann recalls Neodent Easypack Helix GM Acqua 3.5x13mm implants that were mislabeled as 3.5x8mm. This mislabeling could lead to incorrect implant placement. Affected units have specific article numbers and lot codes.
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Take action
Contact the company
📍Recalling firmStraumann USA LLC60 Minuteman Rd · Andover, MA 01810-1008
“Straumann Neodent Easypack Helix GM Acqua 3.5x13mm Mislabeled Implant Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61489-straumann-neodent-easypack-helix-gm-acqua-3-5x13mm-mislabeled-implant. Based on FDA recall #Z-0513-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2022%22&limit=1).
Straumann USA LLC recalled Neodent Easypack Helix GM Acqua implants with Article Number 138.107 due to mislabeling hazards, according to the FDA on November 30, 2021.
The recall addresses mislabeled cartons where the implant dimensions do not match the packaging description. Specifically, Carton box item 138.089 contains a 3.5x13mm implant while labeled as such, but Carton Box 138.107 contains a 3.5x8mm implant instead of the expected 3.5x13mm implant.
Context
GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Other recent recalls include a GM Helix Implant packaging mismatch dated August 12, 2026, and a Bone Level Tapered Implant length error dated July 16, 2026.
How to tell if you have this one
Check for the article number 138.107 and lot code GNV20 on the carton box. The UDI (Unique Device Identifier) is 7899878052906. This specific mislabeling affects implants that should be 3.5x13mm but were labeled as 3.5x8mm.
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
Terminated
Distribution
US Nationwide Distribution in the states of FL, IL, OH
Recall number
Product, codes & lots
Quantity
Z-0512-2022
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089; Lot GNV17 UDI: 7899878052722
Look for the article number 138.107 and lot code GNV20 on the carton box.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of FL, IL, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, Ohio.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0513-2022 (November 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0513-2022 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.