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Recall Observatory FDA recall evidence

Device product

Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

Z-1701-2015

April 19, 2015

Class II

Product summary

Firm
Zimmer CAS
Event
Event 71202
Status
Terminated
Classification
Class II
Quantity
78 devices
Official record key
device-enforcement:Z-1701-2015

Official wording

Reason: 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.

Code information: Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135

Distribution pattern: Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.