Medical device recalls Moderate risk

Stryker Instruments Div. of Stryker Corporation recalls Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is u…

Recall date
March 10, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2071-2017
FDA classification
Class II
Brand / firm
Stryker Instruments Div. of Stryker Corporation
Sold / distributed
US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.

Why it was recalled

Product shipped proximate to or past the expiration date listed on the product label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.

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