Stryker Instruments Div. of Stryker Corporation recalls 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product N

Recalled April 4, 2018 · FDA recall Z-1250-2018 · 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

1244

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. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

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