Device product
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Z-1325-2015
Product summary
- Event
- Event 70605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1325-2015
Official wording
Reason: One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Code information: 20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T
Distribution pattern: US Distribution in the state of CA
Derived failure modes
-
Labeling or packaging
mislabeled