Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-1323-2020)

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:

Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

Product Classification:

Class II

Date Initiated: March 14, 2019

Date Posted: February 26, 2020

Recall Number: Z-1323-2020

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: 87 units

Code Information:

857717 (01)07332747083750(10)857717 28-Dec-2018 857597 (01)07332747083750(10)857597 31-Aug-2018 857656 (01)07332747083750(10)857656 22-Oct-2018 818712 (01)07332747083750(10)818712 9-Nov-2018 818747 (01)07332747083750(10)818747 9-Nov-2018 818647 (01)07332747083750(10)818647 10-Oct-2018 857578 (01)07332747083750(10)857578 23-Aug-2018 857610 (01)07332747083750(10)857610 10-Sep-2018 857615 (01)07332747083750(10)857615 13-Sep-2018 857653 (01)07332747083750(10)857653 10-Oct-2018 857677 (01)07332747083750(10)857677 7-Nov-2018 857694 (01)07332747083750(10)857694 3-Dec-2018 857708 (01)07332747083750(10)857708 14-Dec-2018 857711 (01)07332747083750(10)857711 20-Dec-2018 857729 (01)07332747083750(10)857729 8-Jan-2019 857732 (01)07332747083750(10)857732 15-Jan-2019 818682 (01)07332747083750(10)818682 5-Nov-2018 818811 (01)07332747083750(10)818811 18-Dec-2018 Catalog# 37470

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