Z-1316-2020 Class II Terminated
FDA device recall Z-1316-2020 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: 2470 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
- 2470 units
Product Description
Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
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)07332747083767(10)73491 (01)07332747083767(10)73600 (01)07332747083767(10)73296 (01)07332747083767(10)73315 (01)07332747083767(10)73595 Catalog# 37471