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Recall Observatory FDA recall evidence

Device product

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Z-3209-2017

July 10, 2017

Class II

Product summary

Firm
Zimmer Dental Inc
Event
Event 77911
Status
Terminated
Classification
Class II
Quantity
423 products
Official record key
device-enforcement:Z-3209-2017

Official wording

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.

Code information: lot # 62625167 63254074 63455622 63155008 63331292 63432495 63152070 63209557 63254047 62602470 63135399 63240239 63254023 61722820 62593186 62635420 63254006

Distribution pattern: 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)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.