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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PROFESS

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  Class 2 Device Recall Stryker PROFESS see related information
Date Initiated by Firm March 10, 2017
Date Posted April 19, 2017
Recall Status1 Terminated 3 on July 21, 2017
Recall Number Z-2071-2017
Recall Event ID 77008
510(K)Number K141551  
Product Classification Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
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.
Code Information Lot #202085 Stryker Product Number: 6001-420-000
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
269-323-5330
Manufacturer Reason
for Recall		 Product shipped proximate to or past the expiration date listed on the product label.
FDA Determined
Cause 2		 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 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PGW and Original Applicant = STRYKER CORPORATE
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