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 spine has received reports of the disc space distractors failing during surgical procedures.
조치
Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take.
Customers were instructed to examine their inventory and hospital locations to identify the product.
Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced.
Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370.
Return the affected product using the enclosed pre-paid mailing label to
Regulatory Compliance,
Stryker Spine
6 Pearl Court
Allendale, New Jersey 07401
For questions regarding this recall call 201-760-8206.
Nationwide Distribution including AZ, FL, MA, NY, PA, and TX
제품 설명
Disc Space Distractor || Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 || Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.