FDA Device recall Z-0749-2024
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure by Waldemar Link And Kg Mfg Site, citing 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 resec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0749-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-30 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI :04026575245253 Lot / Serial Number: C306165 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2024%22
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