Device product
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
Z-1005-2019
Product summary
- Event
- Event 82125
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1005-2019
Official wording
Reason: Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Code information: Lot Numbers: 63253751 63257915 63291542 UDI: (01) 00889024307858 (17) 210228 (10) 63253751 (01) 00889024307858 (17) 210228 (10) 63257915 (01) 00889024307858 (17) 210430 (10) 63291542
Distribution pattern: Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS
Derived failure modes
-
Unknown
Potentially comingled, resulting in the product in the box potentially not matching the product on the label