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.
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Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
원인
The screw locking cap may fracture when the surgeon rotates it into the locked position.
조치
Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.
Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.