Z-2929-2026 Class II Ongoing
FDA device recall Z-2929-2026 was initiated by Straumann USA LLC on July 13, 2026 and is designated Class II. 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 bon… The recall status is ongoing. Affected quantity: 417 US.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- July 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 417 US
Product Description
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
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
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.
Code Information
UDI-DI 7899878024552 Lot MVXJ9