GM Helix Implant, Endosseous Dental Implant recallZ-2929-2026 · Straumann USA LLC · initiated Jul 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
On July 13, 2026, the firm began notifying customers through a combination of mail, phone, and email. Letters were sent via overnight UPS delivery. Customers were instructed to check their inventory for the affected article/project numbers. If the product is still in inventory, customer should stop use or distribution immediately and quarantine/segregate physically. Product should be returned to Straumann USA, LLC for replacement. If the product has already been implanted, the firm states that implant removal is not required, and no additional patient follow up is required solely due to this recall.
Recall details
- Recall number
- Z-2929-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 13, 2026
- Posted by the FDA
- Aug 10, 2026
- Recalling firm
- Straumann USA LLC
- Quantity
- 417 US
- Product code
- NHA
- FDA submissions
- K163194
- 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.
Product description
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Code information (models, lots, serial numbers)
UDI-DI 7899878024552 Lot MVXJ9
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neodent 109.984JJGC Indústria e Comércio de Materiais Dentários S/A. · IMPLANT, ENDOSSEOUS, ROOT-FORM2 recalls6,188 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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