Device product
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Z-0749-2024
Product summary
- Event
- Event 93662
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0749-2024
Official wording
Reason: Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
Code information: UDI-DI :04026575245253 Lot / Serial Number: C306165
Distribution pattern: US Nationwide distribution in the state of NH.
Derived failure modes
-
Labeling or packaging
Mislabeled