Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-1325-2020)

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:

Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.

Product Classification:

Class II

Date Initiated: March 14, 2019

Date Posted: February 26, 2020

Recall Number: Z-1325-2020

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: 132 units

Code Information:

(01)07332747084092(10)73562 Catalog# 37504

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