1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 444 Femoral Canal Pressurizer instruments (both Medium and Large sizes) due to lack of sterility assurance. Testing found that bioburden levels on these devices exceeded the company's internal acceptable rates. The affected products were distributed across all 50 U.S. states and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom. The recalled Medium size units have Lot Number 17276012, while Large size units have Lot Number 17282012.
The recall notice does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Reason for recall: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Distribution: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom. Quantity: 444 Lot/code info: Lot Number (Medium): 17276012; Lot Number (Large): 17282012 UDI: (01)4546540039552; (01)4546540039569
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.