Howmedica Osteonics Corp.: Medical Device Recall in 2018 - (Recall #: Z-1462-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 30, 2018

Date Posted: May 2, 2018

Recall Number: Z-1462-2018

Event ID: 79600

Reason for Recall:

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

Status: Terminated

Product Quantity: 77 total products

Code Information:

Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated