Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-1311-2020)

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:

Drill Tapered WP 5x10 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.

Product Classification:

Class II

Date Initiated: March 14, 2019

Date Posted: February 26, 2020

Recall Number: Z-1311-2020

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: 264 units

Code Information:

(01)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085

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