Waldemar Link GmbH & Co. KG (Mfg Site) Recall 93662
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
Waldemar Link GmbH & Co. KG (Mfg Site) Recall 93662 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0749-2024 |
| Event ID | 93662 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of NH. |
| Quantity | 1 unit |
| Recall 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 |
| Device Classification | 20240124 |
| Device Code Info | UDI-DI :04026575245253 Lot / Serial Number: C306165 |
| Center Classification Date | 20240118 |
| Recall Initiation Date | 20231130 |
| Recalling Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Initial Notification | |
| Similar To |