Device product
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Z-2376-2018
Product summary
- Event
- Event 80281
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-2376-2018
Official wording
Reason: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Code information: Lot numbers: 45353, 66011, and 75850
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
Derived failure modes
-
Potency or specification failure
out of specification