Reported Jun 10, 2015 · Terminated

Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

Zimmer CAS

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: Zimmer CAS · 75 Queen St #3300 · Montreal, N/A · N/A

Is this the product you have?

  • Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Lot codes and dates
  • Item Number20-8011-013-00
  • Lot Numbers
    • 120265
    • 110623
    • 120659
    • 120794
    • 120659-1
    • 130134
    • 120793
    • 130135
Amount recalled
78 devices

Where it was sold

Why it was recalled

Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.

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

Notice updated May 13, 2016 · Data as of Sep 19, 4:47 PM UTC

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