Reported Jan 24, 2024 · Ongoing

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…

Waldemar Link GmbH & Co. KG (Mfg Site)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt, N/A · N/A

Is this the product you have?

  • Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure
  • Product Code15-2530/05
Lot codes and dates
  • UDI-DI04026575245253
  • Lot / Serial NumberC306165
Amount recalled
1 unit

Where it was sold

  • Nationwide
  • NH

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.