Recall Z-1315-2020— Nobel Biocare Usa Llc

Name: FDA recall Z-1315-2020
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: K990846. Product: Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.. 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

K990846 — AMORPHOUS DIAMOND COATED DRILLNobel Biocare Uas, Inc.·cleared 1999-06-10

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

Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

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.