Reason: Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Distributed: USA Nationwide distributionReason: Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Distributed: Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.Reason: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Distributed: US Distribution OnlyReason: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Distributed: Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.Reason: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Distributed: Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.Reason: Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
Distributed: Nationwide Distribution.Reason: Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Distributed: Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Distributed: USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Distributed: USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Distributed: USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.