—#154817

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.

FDA product code: PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K141551
Affected lot / code info: Lot #202085 Stryker Product Number: 6001-420-000

Why it was recalled

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

Root cause (FDA determination)

Storage

Action the firm took

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 StrykerInstrumentsRecalls@stryker.com 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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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

Timeline

Recall initiated: 2017-03-10
Posted by FDA: 2017-04-19
Terminated: 2017-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.