PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 27, 2024 Initiated: March 11, 2024 #Z-1329-2024

Product Description

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

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.

Details

Units Affected
80 units
Distribution
US Nationwide distribution in the state of Florida.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Baxter Healthcare Corporation. Units affected: 80 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1329-2024.