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
Intervertebral Fusion Device with Bone Graft - Product Code MAX
원인
The label on one side on the ray tfc device (ray cage) is incorrect. it reads 20 mm x 26 mm instead of 20 mm x 21 mm.
조치
Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.
Ray TFC Device with End Caps: || Single Patient use; Sterile; || Stryker Spine || Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. || Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.