Device product
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Z-1324-2020
Product summary
- Event
- Event 84450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1324-2020
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)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481
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.