Recall Z-0513-2022— Straumann USA LLC

Name: FDA recall Z-0513-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-30

Class II · Terminated

Class II FDA medical device recall by Straumann USA LLC, initiated 2021-11-30, terminated 2025-02-05. It names one FDA 510(k) clearance: K203382. Product: Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2021-11-30
Terminated: 2025-02-05
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203382 — Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.·cleared 2021-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.