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: 140.985, 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

Lot, batch or date codesArticle Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

Quantity recalled207 units (54 US, 153 OUS)

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-1863-2025
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: 140.985

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 Arizona California Colorado Florida Georgia Kansas Louisiana Massachusetts Maryland Michigan Nebraska New Hampshire New Jersey New York Ohio Oklahoma Rhode Island South Carolina Tennessee Texas

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: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

Where was it sold?

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

This product is part of a recall event; the main page for the event is GM Helix Acqua Implant, Article Number recalled by Straumann USA.

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025	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
23 Sep 2026Device	CLASS II	GM Helix Implant recalled by Straumann USA	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	Straumann Bone Level Tapered (BLT) Implant, D RC, SLActive recalled	Straumann USA	Other	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide