Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use dev…

Recall date
January 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1462-2018
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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