Z-1329-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

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

These dates say when openFDA published the data file and when RegDataLab last loaded it.