Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-1856-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - 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.

Product Classification:

Class II

Date Initiated: August 9, 2019

Date Posted: May 13, 2020

Recall Number: Z-1856-2020

Event ID: 85159

Reason for Recall:

Packages of abutments (universal base) 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.

Status: Terminated

Product Quantity: 238 pieces

Code Information:

Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated