Stryker Medical Division of Stryker Corporation: Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Is my product affected?

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

• UPC 07613327282566

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling the Surgistool Model 830 (Part Number 0830000000) because four units intended for use only in healthcare facilities were distributed to residential customers and may be in use in home environments. While the product's labeling correctly identifies that it is designed for use by healthcare professionals in medical facilities, home users may not be aware of or fully understand these professional-use instructions.

The affected devices were distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The four recalled units have the following serial numbers: 1202033898, 1206032470, 1406034563, and 1607037109. The recall record does not specify a remedy or required action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 4 units Lot/code info: Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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