Recall Z-2250-2020— Nobel Biocare Usa Llc

Name: FDA recall Z-2250-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-05-28, terminated 2021-02-09. It names one FDA 510(k) clearance: K071370. Product: Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.. Reason: Packaged dental implant healing abutments were found to contain the wrong size device..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2021-02-09
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071370 — NOBELACTIVE INTERNAL CONNECTION IMPLANTNobel Biocare AB·cleared 2007-08-03

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

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Reason for recall

Packaged dental implant healing abutments were found to contain the wrong size device.

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