Class 2 Device Recall GM Helix Implant

• Date Initiated by Firm: July 13, 2026
• Date Posted: August 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2929-2026
• Recall Event ID: 99407
• 510(K)Number: K163194
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
• Code Information: UDI-DI 7899878024552 Lot MVXJ9
• FEI Number: 1000121052
• Recalling Firm/ Manufacturer: Straumann USA LLC; 60 Minuteman Rd; Andover MA 01810-1008
• For Additional Information Contact: Todd Shevlin; 978-747-2560
• Manufacturer 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: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NHA