🏥 Medical Devices • 4,589 recalls
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
Distal tip may become separated from the lumen wire in specific lots.
Medtronic Vascular
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Medical Components, Inc
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
Howmedica Osteonics
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Silk Road Medical
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
DePuy Orthopaedics
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Aomori Olympus Co.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Aomori Olympus Co.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Aomori Olympus Co.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Aomori Olympus Co.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.