Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Reported: January 26, 2022 Initiated: November 30, 2021 #Z-0513-2022
Product Description
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
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
Details
- Recalling Firm
- Straumann USA LLC
- Units Affected
- 1 unit
- Distribution
- US Nationwide Distribution in the states of FL, IL, OH
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107. Recalled by Straumann USA LLC. Units affected: 1 unit.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0513-2022.
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