Device product
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0185-2018
Product summary
- Event
- Event 78350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0185-2018
Official wording
Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Code information: Lot Number: 79607
Distribution pattern: Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
Derived failure modes
-
Unknown
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.