Retiro De Equipo (Recall) de Device Recall Farabeuf Clamp for 3.5mm Screws PRO

Recall

80198

Class 2

Z-2244-2018

2018-05-04

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164838

Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.

On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.