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Jjgc Industria E Comercio De Materials Dentarios Sa Recall 88917

Description: GM Helix Acqua Implant 3.5x10, Article No. 140.944

Jjgc Industria E Comercio De Materials Dentarios Sa Recall 88917 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0203-2022
Event ID88917
Event DescriptionGM Helix Acqua Implant 3.5x10, Article No. 140.944
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity567 (US)
Recall Reason3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
Device Classification20211110
Device Code InfoUDI 7899878024897 Lots GNW15 and GRE82
Center Classification Date20211104
Recall Initiation Date20211011
Recalling FirmJjgc Industria E Comercio De Materials Dentarios Sa
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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