🏥 Medical Devices • 4,589 recalls
Biomet
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
The shell was missing the locking ring.
Biomet 3i
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Stryker Howmedica Osteonics
Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Bard Access Systems
Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.