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.
Stryker endoscopy is recalling all non expired serfas 90 degree energy probes due to reports of fragments of the probe breaking off into the patient.
조치
Stryker sent an Urgent Medical Device Recall letter dated June 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1. Inform individuals within their organization who need to be aware of this device removal.
2. Review inventory of lots of part number 279-350-101 and determine if you have the affected product (all non-expired devices) in stock. Response is required.
3. If no product is found, complete acknowledgement form located on the Stryker Endoscopy recall website endorecall.stryker.com by logging in using the account number and zip code on this letter.
4. If you do have product, segregate the product and call Stryker customer service at 1-800-624-4422 Option 3 to arrange for product return and issuance of credit.
For questions regarding this recall call 408-754-2664.
Worldwide Distribution - US (nationwide) and Internationally to US Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
제품 설명
SERFAS 90 degree Energy Probe, Part Number 279-350-101; || SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels.