CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report

Neodent Easypack Helix GM Acqua 3./Smart 4..5 Article recalled

Straumann USA is recalling Neodent Easypack Helix GM Acqua 3./Smart 4..5 Article Number: 138.107, distributed nationwide in the US. The recall was initiated on 30 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot GNV20: UDI:7899878052906

Quantity recalled1 unit

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-0513-2022
FDA event ID: 89321
Recalling firm: Straumann USA, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2021
FDA classified: 19 Jan 2022
Reported: 26 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

30 Nov 2021	Recall initiated by company
19 Jan 2022	Classified by FDA	+50 days
26 Jan 2022	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

Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant

Product as listed by the FDA

Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

Where it was distributed

US Nationwide Distribution in the states of FL, IL, OH

Nationwide Florida Illinois Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot GNV20: UDI:7899878052906

Where was it sold?

US Nationwide Distribution in the states of FL, IL, OH

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 89321

Reported	Class	Recall	Company	Reason	Where
26 Jan 2022	CLASS II	Neodent Easypack Helix GM Acqua 3./Smart 4..5 -intended recalled	Straumann USA	Labeling Errors	Nationwide

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All 22

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