Recall Z-2529-2018— Nobel Biocare Usa Llc

Name: FDA recall Z-2529-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2018-03-16, terminated 2018-09-11. It names one FDA 510(k) clearance: K072570. 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.. Reason: The product label has missing information, such as the lot number and expiration date, as well as other information..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Terminated: 2018-09-11
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072570 — NOBELACTIVE MULTI UNIT ABUTMENTNobel Biocare AB·cleared 2007-12-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.