Recall Z-1424-2015— Nobel Biocare Usa Llc

Name: FDA recall Z-1424-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-09

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2015-03-09, terminated 2015-12-30. It names 3 FDA 510(k) clearances: K062566, K050258, K023113. Product: Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.. Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Terminated: 2015-12-30
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K062566 — NOBELREPLACE TAPERED CONICAL CONNECTIONNobel Biocare USA, LLC·cleared 2006-12-06
K050258 — GROOVY IMPLANTSNobel Biocare AB·cleared 2005-04-19
K023113 — REPLACE TIUNITE ENDOSSEOUS IMPLANTNobel Biocare Uas, Inc.·cleared 2002-09-26

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

Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.

Reason for recall

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

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