CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Neodent Easypack Helix GM Acqua /Smart .5 Article Number recalled
Straumann USA is recalling Neodent Easypack Helix GM Acqua /Smart .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
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
Questions about this recall
Is Neodent Easypack Helix GM Acqua /Smart .5 Article Number: 138.107 recalled?
Yes. Straumann USA recalled Neodent Easypack Helix GM Acqua /Smart .5 Article Number: 138.107 on 30 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0513-2022.
Why was it recalled?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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