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Recall Observatory FDA recall evidence

Device 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.

Z-2071-2017

March 10, 2017

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 77008
Status
Terminated
Classification
Class II
Quantity
65
Official record key
device-enforcement:Z-2071-2017

Official wording

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

Code information: Lot #202085 Stryker Product Number: 6001-420-000

Distribution pattern: US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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