Straumann USA Llc: Abutment, Implant, Dental, Endosseous
Recall Summary Straumann USA LLC is recalling GM Helix Implants (Article No. 109.984) distributed nationwide because the dental implant inside the package may not match what's printed on the outer label. Installing an incorrect implant could cause bone compression or make installation difficult in patients with adequate bone volume.
- Recalling firm
- Straumann USA LLC
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Reason
- 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
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4684452f-9817-4a46-b5c0-b1017941d910