Device product
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.
Z-2529-2018
Product summary
- Event
- Event 80393
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74 units were distributed to the U.S.
- Official record key
device-enforcement:Z-2529-2018
Official wording
Reason: The product label has missing information, such as the lot number and expiration date, as well as other information.
Code information: Lot #1270802
Distribution pattern: Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.
Derived failure modes
-
Labeling or packaging
label has missing