Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Implants & Prosthetics
π₯ Medical Devices β’ 4,540 recalls
Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
The femoral stem is lacking specified plasma coating.
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Tritanium Patella Inserter Instrument fracture during implantation. .
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Blue Belt Technologies MN
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.