Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-1304-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

Product Classification:

Class II

Date Initiated: March 14, 2019

Date Posted: February 26, 2020

Recall Number: Z-1304-2020

Event ID: 84450

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

(01)07332747065756(10)73502 Catalog# 37049

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

Voluntary or Mandated:

Voluntary: Firm initiated