Device product
THREAD RETRIEVAL DRILL REF 2224
Z-3205-2017
Product summary
- Event
- Event 77911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 products
- Official record key
device-enforcement:Z-3205-2017
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 # 63241114, 63321266, 63426543
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
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.