GM Helix Implant, Endosseous Dental Implant Article No. 109.984
FDA Recall Z-2929-2026 · Posted 2026-08-10
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Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2026-07-13
Product Quantity417 US
Reason for Recall
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
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
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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