CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
GM Helix Acqua Implant, Article Number recalled by Straumann USA
Straumann USA is recalling GM Helix Acqua Implant, Article Number: 140.984, distributed nationwide in the US. The recall was initiated on 1 May 2025 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-1862-2025
- FDA event ID
- 96806
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2025
- FDA classified
- 28 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 May 2025 | Recall initiated by company | |
| 28 May 2025 | Classified by FDA | +27 days |
| 4 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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 Acqua Implant, Article Number: 140.984
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaKansasLouisianaMassachusettsMarylandMichiganNebraskaNew HampshireNew JerseyNew YorkOhioOklahomaRhode IslandSouth CarolinaTennesseeTexas
Questions about this recall
Why was it recalled?
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Which lots are affected?
Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.
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.
Other products in this recall event
1 other product · FDA event 96806| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GM Helix Acqua Implant, Article Number recalled by Straumann USA | Straumann USA | Packaging Defects | Nationwide |
More recalls from Straumann USA
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GM Helix Implant recalled by Straumann USA | Straumann USA | Packaging Defects | Nationwide |
| 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 |
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