FDA-Device2024-03-27Class II

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
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.

Sold states
US Nationwide distribution in the state of Florida.
Affected count
80 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2024

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