Device product
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Z-3249-2018
Product summary
- Event
- Event 80904
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-3249-2018
Official wording
Reason: The implant only has one bolt in the sterile package but it should have had two.
Code information: Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390
Distribution pattern: Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Derived failure modes
-
Unknown
The implant only has one bolt in the sterile package but it should have had two.