Hip Traction Boot Assembly Defect Could Cause Device Detachment
Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm surgical device with a concrete assembly defect that prevents proper function during hip surgery. Detachment could cause patient harm. However, no illnesses or injuries have been reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Baxter Healthcare Corporation is recalling the HDS Traction Boot II (REF AR-6529-23) due to an assembly defect. The locking ridge on the front face of the boot key socket is oriented incorrectly, facing upwards rather than downwards. This prevents the boot from attaching properly to the spar of the traction system, allowing the boot to detach.
The device is designed to position, support, and distract the patient's foot during hip surgery. Detachment during a surgical procedure could compromise patient stability and safety. Approximately 80 units were distributed in Florida.
Patients or healthcare facilities who have received this device should contact Baxter Healthcare Corporation immediately. Do not use the affected units. Check your device serial number against the provided lot codes to determine if your unit is included in this recall.
The recalled product
- 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
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 123510000293
- 123510000294
- 123510000295
- 123510000296
- 123510000298
- 123510000299
- 123510000300
- 123510000764
- 123510000765
- 123510000766
- 123510000767
- 123510000768
- 123510000769
- 123510000770
- 123510000771
- 123510000772
- 123510000773
- 123510000800
- 123510000801
- 123510000802
Distribution
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