Z-1307-2020 Class II Terminated
FDA device recall Z-1307-2020 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: 473 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
- 473 units
Product Description
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
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)07332747065671(10)73280 Catalog# 37076