CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
GM Helix Implant, Endosseous Dental Implant Article No. recalled
Straumann USA is recalling GM Helix Implant, Endosseous Dental Implant Article No. 109.984, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2929-2026
- FDA event ID
- 99407
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2026
- FDA classified
- 10 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 13 Jul 2026 | Recall initiated by company | |
| 10 Aug 2026 | Classified by FDA | +28 days |
| 19 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriMississippiMontana
Questions about this recall
Why was it 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
Which lots are affected?
UDI-DI 7899878024552 Lot MVXJ9
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Straumann USA
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|---|---|---|---|---|---|
| Device | CLASS II | Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled | Straumann USA | Other | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Custom Abutment AS Ti, for Straumann RC, incl recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | Custom Abutment Ti, for Straumann RC, incl recalled | Straumann USA | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Medline Convenience Kits: Dental Pack recalled by Medline Industries | Medline Industries | Sterility | Nationwide |