FDAClass IIAugust 19, 2015

Triathlon PS X3 Tibial Insert recall

Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no…

Why was Triathlon PS X3 Tibial Insert recalled?

Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

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 Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2

Product
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no…
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
26 units
Distribution
Worldwide Distribution - US Nationwide
Recall date
August 19, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls