Z-1322-2020 Class II Terminated
FDA device recall Z-1322-2020 was initiated by Nobel Biocare Usa Llc on March 14, 2019 and is designated Class II. 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… The recall status is terminated (terminated February 15, 2024). Affected quantity: 233 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- March 14, 2019
- Termination Date
- February 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233 units
Product Description
Abutment Screw Retrieval Instrument 3.0/NP - 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.
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.
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.
Code Information
(01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503