Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
Class I - Dangerous
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.
Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
DePuy Orthopaedics
Class I - Dangerous
DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.
On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.