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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
원인
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
조치
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 || TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.