Product Safety Recalls

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Implant Direct Sybron Manufacturing LLC Recall 88859

Description: ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Implant Direct Sybron Manufacturing LLC Recall 88859 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0198-2022
Event ID88859
Event DescriptionImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
Quantity83 implants
Recall ReasonPackaged dental implant contains a different size then the size declared on the labeling.
Device Classification20211110
Device Code Infolot # 166300 / UDI: 10841307101796
Center Classification Date20211103
Recall Initiation Date20210923
Recalling FirmImplant Direct Sybron Manufacturing LLC
Initial Notification Letter
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