FDAClass IIMarch 13, 2024

X3 Triathlon CS Insert NO 7 9 MM recall

X3 TRIATHLON CS INSERT NO 7 9 MM

Why was X3 Triathlon CS Insert NO 7 9 MM recalled?

Potential packaging breaches of inner blister and outer sterile blister.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Part No. 5531-G-709-E; GTIN: 07613327337464; Lot No. KA1Y71; Expiration Date: 11/08/2028.

Product
X3 TRIATHLON CS INSERT NO 7 9 MM
Recalling firm
Howmedica Osteonics Corp.
Quantity
24 units (US)
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Recall date
March 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls