Aesculap Implant Systems Univation X System knee implant devices as follows recall — FDA Z-2510-2021
Malfunction- loosening of the implant resulting in a potential revision surgery
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Potential for a wire protrusion through the left heart vent catheter tip
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Customers have reported an increased number of false positive SARS-CoV-2 results.
Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional…
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection…
Incorrect version of labels were used.
There is a potential for open seals which can compromise sterility.
Incorrect version of labels were used.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Malfunction- loosening of the implant resulting in a potential revision surgery
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Potential for a wire protrusion through the left heart vent catheter tip
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.
Shortening is declared but sub-ingredient Soybean Oil is not declared.
Product contains undeclared coconut.
Undeclared milk, coconut, and walnut. Product contains milk in cream cheese frosting, coconut in the cake batter, and walnuts as garnish around cake.
Butter and buttermilk declared in the ingredients statement but the Contains statement does not declare milk.
Browse recent months with enough recall history for useful comparison.