Recall Z-1302-2020— Nobel Biocare Usa Llc

Name: FDA recall Z-1302-2020
Creator: U.S. Food and Drug Administration
Published: 2019-03-14

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-03-14, terminated 2024-02-15. It names one FDA 510(k) clearance: K030685. Product: Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2019-03-14
Terminated: 2024-02-15
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030685 — TEETH IN AN HOUR - ARK IMPLANT CONCEPTNobel Biocare AB·cleared 2004-02-06

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

Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants

Reason for recall

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

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