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
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde - Product Code OJZ
원인
A change to the preparation for use section
was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved.
조치
The firm, Stryker Biotech, sent a "Medical Device Correction" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty.
If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at PVG@stryker.com.
Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) || "Catalog numbers: 300-50, 300-55 || OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.