FDA-Device2015-06-10Class II
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Zimmer CAS
Hazard
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.
Sold states
Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
Affected count
78 devices
Manufactured in
75 Queen St #3300, N/A, Montreal, N/A, Canada
Products
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1701-2015Don't want to check this manually?
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