U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Clamp - Product Code HXD
원인
Laser etching which indicates whether the device is in
compression or distraction mode appears to be on the wrong side of the lever arm.
조치
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.