Zimmer Biomet Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref recall — FDA Z-0395-2019
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Synchronization failure
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick…
Complaints where users were unable to prime the administration set.
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some…
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and…
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Incorrect package labeling identifying the device
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power…
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic…
The reagent pack exhibits the potential for an increased frequency of calibration failures.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature…
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Abnormally high INR test results with the affected CoaguChek test strips
Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result…
Incorrect package labeling identifying the device
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
There is a potential for comingling of the 43MM and 51 MM molds
Browse recent months with enough recall history for useful comparison.