FDA recall Z-2529-2018

Nobel Biocare Usa Llc · Class II · 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.

Reason for recall

The product label has missing information, such as the lot number and expiration date, as well as other information.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-03-16
Report date
2018-08-01
Termination date
2018-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2018