Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 recall: Labeling Error
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Why was Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot GNV17 UDI: 7899878052722
- Product
- Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
- Recalling firm
- Straumann USA LLC
- Quantity
- 7 pieces
- Distribution
- US Nationwide Distribution in the states of FL, IL, OH
- Recall date
- January 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)