Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 80 units |
| Distribution | US Nationwide distribution in the state of Florida. |
| Initiated | 2024-03-11 |
| Classified | 2024-03-20 |
| Recall number | Z-1329-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-1329-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94202/
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