Reported Jan 26, 2022 · Terminated
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
- Lot codes and dates
- Lot GNV17 UDI7899878052722
- Amount recalled
- 7 pieces
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Straumann USA LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.