Product Safety Recalls

Product Recall Tracker

Straumann USA LLC Recall 89321

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

Straumann USA LLC Recall 89321 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0512-2022
Event ID89321
Event DescriptionNeodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Product TypeDevices
DistributionUS Nationwide Distribution in the states of FL, IL, OH
Quantity7 pieces
Recall ReasonMislabeled: 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
Device Classification20220126
Device Code InfoLot GNV17 UDI: 7899878052722
Center Classification Date20220119
Recall Initiation Date20211130
Recalling FirmStraumann USA LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.