Z-2071-2017Class II

Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation...

Name: Z-2071-2017 Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2017-03-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-03-10 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system... on 2017-03-10. FDA classified it as Class II and gives the reason as "Product shipped proximate to or past the expiration date listed on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2071-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-10
Posted: 2017-04-19
Terminated: 2017-07-21
Recalling firm: Stryker Corp.
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.
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
Reason for recall: Product shipped proximate to or past the expiration date listed on the product label.
Root cause tag: labeling and UDI
FDA root cause: Storage
Action: Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated March 10, 2017, to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions to be Taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any recalled PROFESS Registration Kits. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected] 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product(s), replacement products will be shipped to your account. For further questions please call (269) 323-5330.
Quantity in commerce: 65
Distribution: US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
Product codes and lots: Lot #202085 Stryker Product Number: 6001-420-000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2071-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-11

Product code PGW

K141551Class IIProfess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees)Stryker Corporate / cleared 2014-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)