Device product
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Z-1311-2020
Product summary
- Event
- Event 84450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264 units
- Official record key
device-enforcement:Z-1311-2020
Official wording
Reason: 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.
Code information: (01)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085
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.
Derived failure modes
-
Unknown
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.