Potential for compromise of the package resulting in a breach of the sterile barrier
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
DAL-RO Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
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.
Certain Pick-up Coping Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
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.
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Straumann Manufacturing
Class I - Dangerous
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
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
Pouches may not have been sealed during packing.
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.
IOL 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.
IOL Distal Extension 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.
Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. UPDATE 9/1/2016 Baxter issued a notice retrieving 6 lots of VASCU-GUARD due to the increased postmarketing reports related to intraoperative and postoperative bleeding.
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.
Temporary Hexed Cylinder Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.