Device product
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Z-0630-2019
Product summary
- Event
- Event 81604
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-0630-2019
Official wording
Reason: Screw is missing from the package
Code information: Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Derived failure modes
-
Unknown
Screw is missing from the package