Z-1329-2024Class II

HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the...

Name: Z-1329-2024 HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the...
Creator: Baxter Healthcare Corporation
Published: 2024-03-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-03-11 / Open, Classified

FDA source

Baxter Healthcare Corporation began a 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 on 2024-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1329-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-11
Posted: 2024-03-20
Recalling firm: Baxter Healthcare Corporation
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
Product code: HST Apparatus, Traction, Non-Powered
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.
FDA root cause: Under Investigation by firm
Action: Baxter issued an Urgent Medical Device Recall notice to its sole consignee on 03/11/2024 via email. The notice explained the issue and potential hazard and requested the following: 1. Immediately locate, isolate, and cease all use of the affected serial numbers of the product. The product code and serial number can be found on labelling on the bottom of the boot. 2. Arrange for the return of your impacted product by calling the Baxter Order Management Team at 800-433-5774, option 2 then 3, between the hours of 8:00 am and 5:00 pm Eastern Time, Monday through Friday, or by emailing Baxter at [email protected]. 3. Acknowledge the receipt of this notification by completing a reply form on the customer portal.
Quantity in commerce: 80 units
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

Product code HST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)