Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-2250-2020)

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:

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.

Product Classification:

Class II

Date Initiated: May 28, 2019

Date Posted: June 10, 2020

Recall Number: Z-2250-2020

Event ID: 85530

Reason for Recall:

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

Status: Terminated

Product Quantity: 234 pieces globally, of which 16 were sent to the US.

Code Information:

Lot 13076845

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated