HDS Traction Boot II — Class II medical device recall Z-1329-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-03-27, distributed nationwide. Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Tract
| Recall number | Z-1329-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-03-11 |
| Classified | 2024-03-20 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 80 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00123350000992, 00123350001036, 00123360000302, 00123360000739, 00123360001972, 00123510000299, 00123510000770, 00123510000800 |
| Model numbers | AR-6529-23 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1329-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.