Recall Z-2929-2026
Straumann USA LLC · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Codes / lots: UDI-DI 7899878024552 Lot MVXJ9
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
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2929-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 10, 2026
- Product code
- NHA – Abutment, Implant, Dental, Endosseous
- Quantity
- 417 US
- 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.
- Recalling firm
- Straumann USA LLC, Andover, MA