Retiro De Equipo (Recall) de Device Recall Stryker PROFESS

Recall

77008

Class 2

Z-2071-2017

2017-03-10

2017-04-19

Terminated

United States

2017-07-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154817

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

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.