FDA recall Z-2250-2020

Product

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - 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. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Reason for recall

Packaged dental implant healing abutments were found to contain the wrong size device.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.

Key facts

Status

Terminated

Initiation date

2019-05-28

Report date

2020-06-10

Termination date

2021-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2020