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Stryker Instruments Div. of Stryker Corporation recalls 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPu
Recalled April 4, 2018 · FDA recall Z-1246-2018 · 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
5988
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. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →