FDA-Device2024-01-24Class II
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)
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
Sold states
US Nationwide distribution in the state of NH.
Affected count
1 unit
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0749-2024Don't want to check this manually?
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