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
Bone Wedge - Product Code PLF
원인
Potential for polystyrene particulate presence.
조치
On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.