Device product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Z-2046-2023
Product summary
- Event
- Event 92500
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-2046-2023
Official wording
Reason: The firm discovered through customer complaints that device segments may not meet specifications.
Code information: Item No. 15-2973/05; UDI-DI: 04026575340699.
Distribution pattern: Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Derived failure modes
-
Potency or specification failure
may not meet specifications