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Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

FDA Recall #Z-0512-2022 — Class II — November 30, 2021

Recall #Z-0512-2022 Date: November 30, 2021 Classification: Class II Status: Terminated

Product Description

Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

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

Recalling Firm

Straumann USA LLC — Andover, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7 pieces

Distribution

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

Code Information

Lot GNV17 UDI: 7899878052722

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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