Stryker Instruments Div. of Stryker Corporation recalls 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use

Recalled April 4, 2018 · FDA recall Z-1247-2018 · 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

900

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

11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

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