Summary
The FDA issued a Class II for GM Helix Implant, Endosseous Dental Implant Article No. 109.984 by Straumann USA LLC. 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 incorre.
Details
Source
Device Recall
External ID
Z-2929-2026
Action Date
2026-08-19
Status
Ongoing
Category
device
Product Description
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Lot/Code Info: UDI-DI 7899878024552 Lot MVXJ9
Quantity Affected: 417 US
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.
Straumann USA LLC has 17 FDA actions in our database, including 16 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Straumann USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Straumann USA LLC have FDA actions?
Straumann USA LLC has 17 FDA actions in our database, including 16 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2929-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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