FDA Device recall Z-1329-2024
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
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of 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 by Baxter Healthcare, citing 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 lockin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1329-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-11 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | 123510000293, 123510000294, 123510000295, 123510000296, 123510000298, 123510000299, 123510000300, 123510000764, 1235100…123510000293, 123510000294, 123510000295, 123510000296, 123510000298, 123510000299, 123510000300, 123510000764, 123510000765, 123510000766, 123510000767, 123510000768, 123510000769, 123510000770, 123510000771, 123510000772, 123510000773, 123510000800, 123510000801, 123510000802, 123510000803, 123510000804, 123510000805, 123510000806, 123510000807, 123510000808, 123510000809, 123510000297, 123350001033, 123350001034, 123350001035, 123350001036, 123350001040, 123350001041, 123350001042, 123360000294, 123360000295, 123360000297, 123360000298, 123360000299, 123360000300, 123360000301, 123360000302, 123360000303, 123360000304, 123360000733, 123360000734, 123360000735, 123360000736, 123360000737, 123360000738, 123360000739, 123360000740, 123360001972, 123360001973, 123360001974, 123360001975, 123360001976, 123360001977, 123360001978, 123360001979, 123360001980, 123360001981, 123350000968, 123350000969, 123350000970, 123350000971, 123350000972, 123350000973, 123350000974, 123350000975, 123350 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1329-2024%22
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