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Baxter Healthcare Corporation recalls HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f
Recalled March 27, 2024 · FDA recall Z-1329-2024 · Baxter Healthcare
Hazard
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. · FDA Class II
Units
80 units
Sold at
US Nationwide distribution in the state of Florida.
Description
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.
Product
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
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →