GM Helix Implant, REF: 109.984;
FDA Recall Z-3173-2026 · Posted 2026-09-15
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Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeDZE
Date Initiated2026-08-12
Product Quantity216
Reason for Recall
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Firm Action
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]
Root Cause
Under Investigation by firm
Distribution Pattern
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;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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