FDA-Device2017-10-04Class II

THREAD RETRIEVAL DRILL REF 2224

Zimmer Dental Inc
Hazard

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.

Sold states
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)
Affected count
237 products
Manufactured in
1900 Aston Ave, N/A, Carlsbad, CA, United States
Products
THREAD RETRIEVAL DRILL REF 2224

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3205-2017

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