CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
GM Helix Implant recalled by Straumann USA
Straumann USA is recalling GM Helix Implant, distributed nationwide in the US. The recall was initiated on 12 Aug 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-3173-2026
- FDA event ID
- 99707
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2026
- FDA classified
- 15 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 12 Aug 2026 | Recall initiated by company | |
| 15 Sep 2026 | Classified by FDA | +34 days |
| 23 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
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, REF: 109.984;
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasLouisianaMassachusettsMichiganMissouriNorth CarolinaNew JerseyNevadaNew YorkOhioOklahomaOregonPennsylvania
Questions about this recall
Why was it recalled?
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Which lots are affected?
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
Where was it sold?
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, 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 29 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 | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| 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 |
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