Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2529-2018

March 16, 2018

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 80393
Status
Terminated
Classification
Class II
Quantity
74 units were distributed to the U.S.
Official record key
device-enforcement:Z-2529-2018

Official wording

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

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label has missing