Triathlon Tritanium Tibial Component recall: Labeling Error
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Why was Triathlon Tritanium Tibial Component recalled?
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
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?
Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
- Product
- Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 22 units (12 US; 10 OUS)
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
- Recall date
- June 15, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)