medical Class II Updated 2021-08-18

Stryker Medical Division of Stryker Corporation recalls Surgistool-intended to support a healthcare professional dur

Recalled Product

Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Hazard / Issue

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566
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