GM Helix Implant recall
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Why was GM Helix Implant recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 7899878024552 Lot MVXJ9
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Recalling firm
- Straumann USA LLC
- 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.
- Recall date
- August 19, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)