Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Check against the official notice below — it lists the full affected range.
Stryker has recalled Triathlon Tritanium Tibial Components (Size 6, Catalog Number 5536-B-600 and Size 5, Catalog Number 5536-B-500) due to a potential product mix where the component inside the package does not match the size indicated on the package labeling. A total of 22 units were affected, consisting of 12 units distributed in the US states of Alabama, California, Colorado, Idaho, Indiana, Kansas, Michigan, Nevada, Pennsylvania, Tennessee, Washington, and West Virginia, and 10 units distributed outside the US in the United Kingdom and Poland.
The affected products are identified by lot codes CTD69463 (Size 6) and CTD69106 (Size 5). The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 22 units (12 US; 10 OUS) Lot/code info: Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.