Class I - Dangerous
Pouches may not have been sealed during packing.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Certain Locator Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Class I - Dangerous
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
Index Coping Surgical Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
Conical Healing Cap Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Class I - Dangerous
Pouches may not have been sealed during packing.
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Potential for compromise of the package resulting in a breach of the sterile barrier