Nobel Biocare Usa Llc: Medical Device Recall in 2015 - (Recall #: Z-1439-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.

Product Classification:

Class II

Date Initiated: March 9, 2015

Date Posted: April 22, 2015

Recall Number: Z-1439-2015

Event ID: 70821

Reason for Recall:

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Status: Terminated

Product Quantity: 53 units

Code Information:

Batch No. 13010961, 13013308

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated