Device product
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Z-1309-2020
Product summary
- Event
- Event 84450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260 units
- Official record key
device-enforcement:Z-1309-2020
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)07332747065626(10)73474 (01)07332747065626(10)73369 Catalog# 37081
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.