Z-2376-2018 Class II Terminated
FDA device recall Z-2376-2018 was initiated by Implant Direct Sybron Manufacturing, LLC on May 18, 2018 and is designated Class II. Reason for recall: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant The recall status is terminated (terminated July 13, 2020). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- May 18, 2018
- Termination Date
- July 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Reason for Recall
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Distribution Pattern
CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
Code Information
Lot numbers: 45353, 66011, and 75850