Baxter Healthcare recalls HDS Traction Boot II (REF AR-6529-23) due to incorrect assembly causing boot detachment from traction system during hip surgery. Affected units have specific serial numbers.
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.
Baxter Healthcare is recalling certain Hip Distraction System Traction Boots because they were assembled incorrectly. This causes the boot to detach from the traction system during hip surgery, potentially leading to complications.
The traction boot's locking ridge faces upward instead of downward during assembly. This prevents the boot from attaching properly to the traction system's spar, causing it to detach during use. Detachment could lead to improper positioning of the patient's hip during surgery.
Patients undergoing hip surgery who use the recalled Traction Boot II are affected. Medical professionals using the device for hip surgery are at risk if they have the incorrect assembly.
Check for the model number AR-6529-23 on the product. Affected units have specific serial numbers listed in the recall notice, including 123510000293 through 123360001981.
Verify the locking ridge on the front face of the boot key socket faces downward, not upward.
The traction boot was assembled incorrectly, causing the locking ridge to face upward instead of downward. This prevents proper attachment to the traction system's spar, risking detachment during hip surgery.
Check if your unit has the model number AR-6529-23 and the listed serial numbers. If it does, verify the assembly by checking the locking ridge direction. Contact Baxter Healthcare for further instructions.
The recall record does not specify a remedy or fix. Affected units should be checked for proper assembly and contacted with questions.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1329-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1329-2024 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
