Medical Device Recall: HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Baxter Healthcare Corporation · March 11, 2024
Reason for Recall
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
Distribution
US Nationwide distribution in the state of Florida.
States Affected
NATIONWIDE
Quantity Affected
80 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1329-2024
Status: ongoing
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