Nobel Biocare Usa Llc: Medical Device Recall in 2016 - (Recall #: Z-2237-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.

Product Classification:

Class II

Date Initiated: June 22, 2016

Date Posted: July 27, 2016

Recall Number: Z-2237-2016

Event ID: 74486

Reason for Recall:

Incorrect top label on an implant package.

Status: Terminated

Product Quantity: 53 units total (33 units in US)

Code Information:

13030677

Distribution Pattern:

Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC

Voluntary or Mandated:

Voluntary: Firm initiated