Z-1701-2015 Class II Terminated
FDA device recall Z-1701-2015 was initiated by Zimmer CAS on April 19, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 13, 2016). Affected quantity: 78 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2015
- Initiation Date
- April 19, 2015
- Termination Date
- May 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 devices
Product Description
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
Code Information
Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135