FDA recall Z-1462-2018

Product

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.

Reason for recall

Customers may receive the incorrect size implant from what is labeled on the box.

Distribution

USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA

Key facts

Status

Terminated

Initiation date

2018-01-30

Report date

2018-05-02

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2018