PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 17, 2017 Initiated: March 10, 2017 #Z-2071-2017

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.

Details

Units Affected
65
Distribution
US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
Location
Portage, MI

Frequently Asked Questions

What product 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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 65.
Why was this product recalled?
Product shipped proximate to or past the expiration date listed on the product label.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2071-2017.