Z-1701-2015 Class II Terminated

Recalled by Zimmer CAS — Montreal, N/A

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