Z-0749-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the state of NH.
Code Information
UDI-DI :04026575245253 Lot / Serial Number: C306165