Z-0363-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 26, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 implants
Product Description
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reason for Recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Distribution Pattern
US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Code Information
Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023