FDAFDA · Food and drugs·Recall number 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. Product Code: 15-2530/05
Published January 24, 2024 · Recall initiated: November 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Distributor
- US Nationwide distribution in the state of NH.
- Lot
- UDI-DI :04026575245253 Lot / Serial Number: C306165
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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