Stryker Instruments Div. of Stryker Corporation recalls 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product

Recalled April 4, 2018 · FDA recall Z-1254-2018 · 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

504

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. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 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 →