Nobel Biocare Usa Llc: Medical Device Recall in 2018 - (Recall #: Z-2529-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

Product Classification:

Class II

Date Initiated: March 16, 2018

Date Posted: August 1, 2018

Recall Number: Z-2529-2018

Event ID: 80393

Reason for Recall:

The product label has missing information, such as the lot number and expiration date, as well as other information.

Status: Terminated

Product Quantity: 74 units were distributed to the U.S.

Code Information:

Lot #1270802

Distribution Pattern:

Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated