Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
Class I - Dangerous
The set screw is not able to advance or reverse from the original position in the nail.
A size 22mm threaded peg was found in the package of a 10mm unit.
Class I - Dangerous
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Class I - Dangerous
Incorrect use-by date on the device registration/patient file labels.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
DePuy Orthopaedics
Class I - Dangerous
This unit may be missing the screw/collet Assembly
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Mako Surgical
Class I - Dangerous
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Mako Surgical
Class I - Dangerous
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Smith & Nephew
Class I - Dangerous
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
Class I - Dangerous
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Zimmer Biomet
Class I - Dangerous
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Sorin CRM SAS
Class I - Dangerous
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
Mix-up between adult and pediatrics PD catheter.
Class I - Dangerous
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Sorin CRM SAS
Class I - Dangerous
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.