GM Helix Implant, REF: 109.984 recallZ-3173-2026 · Straumann USA LLC · initiated Aug 12, 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 is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant removal is not required, and no additional patient follow -up is required solely due to this recall 5. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to [email protected]
Recall details
- Recall number
- Z-3173-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2026
- Posted by the FDA
- Sep 15, 2026
- Recalling firm
- Straumann USA LLC
- Quantity
- 216
- Product code
- DZE
- FDA submissions
- K163194
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
Product description
GM Helix Implant, REF: 109.984;
Code information (models, lots, serial numbers)
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
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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