PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 1, 2018 Initiated: March 16, 2018 #Z-2529-2018

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.

Reason for Recall

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

Details

Recalling Firm
Nobel Biocare Usa Llc
Units Affected
74 units were distributed to the U.S.
Distribution
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.
Location
Yorba Linda, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Nobel Biocare Usa Llc. Units affected: 74 units were distributed to the U.S..
Why was this product recalled?
The product label has missing information, such as the lot number and expiration date, as well as other information.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2529-2018.