BEUDAMED
    FDA Recall Terminated

    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

    Recall: Z-3208-2017 · Initiated July 10, 2017

    Recall

    Recall Number
    Z-3208-2017
    Event Number
    77911
    Firm
    Zimmer Dental Inc
    FEI Number
    2023141
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 10, 2017
    Terminated
    August 5, 2019
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

    Reason

    Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

    Action

    The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

    Distribution

    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

    Quantity

    86 products