Z-1329-2024 Class II Ongoing
FDA device recall Z-1329-2024 was initiated by Baxter Healthcare Corporation on Mar 11, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 80 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Mar 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
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.
Distribution Pattern
US Nationwide distribution in the state of Florida.
Code Information
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, 123350000987, 123350000988, 123350000989, 123350000990, 123350000991, 123350000992, 123350000993, 123350000994, 123350001032
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1329-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026