FDAClass IIMay 2, 2018

Triathlon Revision Knee recall

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…

Why was Triathlon Revision Knee recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Howmedica Osteonics Corp.
Quantity
77 total products
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
Recall date
May 2, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls