FDAClass IIAugust 25, 2021

Triathlon Prim CEM FXD BPLT 7 recall

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Why was Triathlon Prim CEM FXD BPLT 7 recalled?

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

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?

Lot JHS2H

Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Recalling firm
Howmedica Osteonics Corp.
Quantity
14 US; 2 OUS
Distribution
Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls