FDAClass II · Medical device · Recall Z-2929-2026 · Recalled August 19, 2026

GM Helix Implant recall — Straumann USA LLC

Agency report date: August 19, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: GM Helix Implant
Company / brand: Straumann USA
Lot / serial / date codes: UDI-DI 7899878024552 Lot MVXJ9
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.

Agency product description and boundaries

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: GM Helix Implant

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2929-2026
Brand: Straumann USA
Classification: Class II
Units affected: 417 US
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

GM Helix Implant

Companies & origin

Recalling firm location: Andover, MA, United States
Firm address: 60 Minuteman Rd, 01810-1008

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI 7899878024552 Lot MVXJ9
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.
Firm notified the public via: Letter
FDA event ID: 99407
Recall initiated: July 13, 2026
FDA classified: August 10, 2026
FDA report date: August 19, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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