Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Reported: June 15, 2022 Initiated: March 30, 2022 #Z-1237-2022
Product Description
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Reason for Recall
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 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.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500. Recalled by Howmedica Osteonics Corp.. Units affected: 22 units (12 US; 10 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1237-2022.
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