Z-3207-2017 Class II Terminated

Recalled by Zimmer Dental Inc — Carlsbad, CA

FDA device recall Z-3207-2017 was initiated by Zimmer Dental Inc on July 10, 2017 and is designated Class II. Reason for recall: 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 supp… The recall status is terminated (terminated August 5, 2019). Affected quantity: 76 products.

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
July 10, 2017
Termination Date
August 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
76 products

Product Description

TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT

Reason for Recall

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.

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)

Code Information

lot # 63145351, 63202941, 60646055, 62353334, 63316134