Z-2529-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- March 16, 2018
- Termination Date
- September 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units were distributed to the U.S.
Product Description
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.
Reason for Recall
The product label has missing information, such as the lot number and expiration date, as well as other information.
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.
Code Information
Lot #1270802