Device product
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
Z-3206-2017
Product summary
- Event
- Event 77911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,235 products
- Official record key
device-enforcement:Z-3206-2017
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 # 63196608, 63224322, 63260962, 63327428, 63327427, 63346417, 63355661, 63355664, 63355665, 63376660, 63376662, 63376661, 63376663, 63395410, 63395405, 63395406, 63395407, 63395404, 63406219, 63406221, 63419209, 63419210, 63456331, 63456332, 63465599, 63466907, 63466908, 63474628, 63477075, 63488535, 63484450, 63488536, 63497308, 63497305, 63497307, 63510220, 63525249, 63525250, 63530399, 63529116, 63556373, 63561213, 63231611, 63232148, 63235422, 63260202, 63260203, 63346423, 63346421, 63356678, 63356675, 63376655, 63376657, 63376654, 63376653, 63376656, 63395415, 63395413, 63395414, 63403215, 63406224, 63406223, 63423431, 63447115, 63493319, 63493321, 63493320, 63497313, 63497311, 63494469, 63497310, 63497315, 63503047, 63510221, 63514475, 63517534, 63556374, 61286832, 62665080, 63193089, 63284657, 63355672, 63376713, 63395418, 63401354, 63412145, 63456336, 63474629, 63505401, 62591831, 63327432, 63376658, 63395428, 63447117, 63456337, 63517538, 63556375, 62644526, 63193906, 63232146, 63284601
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.