Reason: Labeling inconsistency
Distributed: Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.Reason: Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of
Distributed: Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.Reason: Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
Distributed: USA Nationwide Distribution in the states of VA, CA, Ky, and INReason: It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.Reason: Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Distributed: US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.Reason: The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
Distributed: Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.Reason: It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
Distributed: Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.Reason: Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
Distributed: Nationwide distribution including Puerto Rico.Reason: Expired active ingredient was used in the manufacture of the product.
Distributed: Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.Reason: Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include: Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.