Abut Gold Friction-fit recall
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…
Why was Abut Gold Friction-fit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Zimmer Dental Inc
- Quantity
- 13,235 products
- 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)
- Recall date
- October 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)