Reason: Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
Distributed: .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOMReason: The products may have been stored at temperatures outside their required storage conditions.
Distributed: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.Reason: The products may have been stored at temperatures outside their required storage conditions.
Distributed: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.Reason: The products may have been stored at temperatures outside their required storage conditions.
Distributed: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.Reason: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion
Distributed: Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.Reason: It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
Distributed: US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.Reason: A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered.
Distributed: US Distribution including the states of CA, CO, FL, KS and PA.Reason: The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
Distributed: Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.Reason: Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
Distributed: Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.Reason: Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
Distributed: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and Puerto Rico, and the country of Iceland.