Recall Z-2071-2017— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-2071-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-10

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-03-10, terminated 2017-07-21. It names one FDA 510(k) clearance: K141551. Product: 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.. Reason: Product shipped proximate to or past the expiration date listed on the product label..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-03-10
Terminated: 2017-07-21
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K141551 — PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)Stryker Corporate·cleared 2014-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.