Stryker Instruments Div. of Stryker Corporation recalls 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral

Recalled April 4, 2018 · FDA recall Z-1245-2018 · Stryker Instruments Div. of Stryker

Hazard

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. · FDA Class II

Units

444

Sold at

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.

Description

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Product

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.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →