NOBEL BIOCARE SERVICES AG: Medical Device Recall in 2020 - (Recall #: Z-2828-2020)

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:

NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

Product Classification:

Class II

Date Initiated: July 20, 2020

Date Posted: August 26, 2020

Recall Number: Z-2828-2020

Event ID: 86085

Reason for Recall:

Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

Status: Terminated

Product Quantity: 188

Code Information:

Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated