FDA recall Z-1852-2020

Nobel Biocare Usa Llc · Class II · device

Product

Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

Reason for recall

Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.

Key facts

Status
Terminated
Initiation date
2019-08-09
Report date
2020-05-13
Termination date
2021-12-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1852-2020