Townsend Design: Custom Sprystep and Vector Orthoses Recalled for Structural Breakage Risk

Agency Publication Date: January 5, 2024

Summary

Townsend Design has recalled approximately 1,480 Custom Sprystep and Sprystep Vector ankle-foot and knee-ankle-foot orthoses due to a manufacturing defect. Air pockets trapped between the layers of material can cause the brace to break completely during use. These custom-made medical devices were distributed across nearly every U.S. state and several international locations between September 2023 and early 2024.

Risk

The presence of air pockets weakens the structural integrity of the orthosis, which can lead to a sudden and complete breakage of the device while the patient is walking or standing, potentially causing a fall and serious injury.

What You Should Do

Identify if your brace is affected by checking the model name (Custom Sprystep, Sprystep Vector, or Sprystep Vector KAFO) and matching your Order Number against the list of 1,480 affected units, which include reference numbers such as 17C1000, 17V1031, and 17VKCUS.
Check your device for UDI numbers on the packaging or documentation, such as (01)04035459406987 for the Custom Sprystep or (01)04035459407045 for the Sprystep Vector.
Contact your healthcare provider, orthotist, or the professional who fitted your brace immediately to determine if your specific custom unit is part of this recall and to discuss the safety of continued use.
Contact Townsend Design directly at their Bakersfield, California facility for further instructions regarding a replacement or repair of the defective device.
Report any incidents of breakage or injuries to the FDA's MedWatch Program online or by calling 1-800-332-1088.
For additional questions, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction for structural breakage risk

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO)

Model / REF:

17C1000

17C2000

17C1010

17C2010

17C1040

17C2040

Lot Numbers:

Order #s: 875138, 873876, 870246, 878309, 870876, 867906, 867207, 874519, 870238, 872326, 880231, 877998, 881515, 876713, 873527, 865318, 872900, 879715, 871401, 876266, 869208, 878409, 872012, 881081, 876737, 873872, 873873, 873874, 881432, 879731, 869605, 870645, 872295, 877649, 880838, 871165, 881042, 867389, 872007, 879027, 872785, 876112, 876597, 869483, 876193, 881451, 872018, 869463, 879627, 874007, 877229, 873391, 871394, 872322, 879239, 880900, 878438, 878984, 869479, 866311

Order #s: 877272, 873876, 878309, 870876, 878859, 870238, 872332, 881515, 865113, 871377, 873527, 865318, 872900, 876830, 879719, 876266, 869208, 878409, 879736, 877464, 881087, 876758, 882039, 881432, 868575, 869605, 870239, 880069, 881858, 881004, 871167, 877863, 879027, 872785, 876112, 872231, 867679, 867192, 869483, 874204, 871980, 872018, 869463, 876197, 874007, 877229, 877657, 877032, 877686, 878973, 871394, 878061, 877487, 873224, 879239, 878438, 878984, 881309, 869479, 869481, 867818, 881671

Product: SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO)

Model / REF:

17V1030

17V2030

17V1031

17V2031

17V1032

17V2032

17V1033

17V2033

17V1035

17V2035

17V1036

17V2036

17V1037

17V2037

Lot Numbers:

Order #s: 877130, 871608, 869477, 873755, 873408, 873462, 872532, 871154, 880168, 880929, 865865, 873716, 866700, 870221, 871517, 875929, 877106, 877351, 871959, 875613, 866847, 882306, 881541, 869191, 869393, 875444, 872004, 867991, 880396, 868574, 877787, 876488, 879697, 866838, 875675, 877656, 867391, 873489, 869196, 872232, 870921, 867678, 868728, 877709, 867990, 879513, 869349, 869864, 880431, 879922, 882026, 872429, 876236, 871997, 881374, 880275, 876177, 869274, 870606, 879926, 871392, 878189, 869601, 867903, 876762, 867908, 867780, 873752, 867175, 872533, 879230

Product: SPRYSTEP VECTOR KAFO, Custom made device dynamic knee-ankle-foot orthosis

Model / REF:

17VKCUS

17VKCUSX

Lot Numbers:

Order #s: 868003, 864980, 877514, 867899, 875411, 868308, 871161, 865211, 881621, 872534, 881616, 865744, 866309, 876670, 877270, 864959, 869294, 868549, 864957, 864595, 866551, 866682, 863308, 875500, 873400, 865509, 868828, 875846, 877677, 869358, 876200, 873155, 867381, 878188, 870222, 869927, 873860, 865503, 878668, 878182, 863772, 866842, 878791, 865507, 863707, 872687, 868289, 873685, 870922, 864367, 865966, 875463, 871512, 870916, 866919, 879216, 878252, 879014, 874428, 867045, 878412, 863471, 871544, 874438, 872200, 870646, 872512, 865508, 876593, 869370, 865720, 863470, 876045, 867371, 865737, 868736, 873157, 867694, 875149, 867457, 875554, 863353, 867286, 873781, 873357, 867357, 873861, 871137

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93299

Status: Resolved

Manufacturer: Townsend Design

Sold By: Orthotics clinics; Healthcare providers; Authorized distributors

Manufactured In: United States

Units Affected: 3 products (248 units; 898 units; 334 units)

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your brace is affected by checking the model name (Custom Sprystep, Sprystep Vector, or Sprystep Vector KAFO) and matching your Order Number against the list of 1,480 affected units, which include reference numbers such as 17C1000, 17V1031, and 17VKCUS.

Check your device for UDI numbers on the packaging or documentation, such as (01)04035459406987 for the Custom Sprystep or (01)04035459407045 for the Sprystep Vector.

Contact your healthcare provider, orthotist, or the professional who fitted your brace immediately to determine if your specific custom unit is part of this recall and to discuss the safety of continued use.

Contact Townsend Design directly at their Bakersfield, California facility for further instructions regarding a replacement or repair of the defective device.

Report any incidents of breakage or injuries to the FDA's MedWatch Program online or by calling 1-800-332-1088.

For additional questions, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO)

Model / REF:

17C1000

17C2000

17C1010

17C2010

17C1040

17C2040

Lot Numbers:

Product: SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO)

Model / REF:

17V1030

17V2030

17V1031

17V2031

17V1032

17V2032

17V1033

17V2033

17V1035

17V2035

17V1036

17V2036

17V1037

17V2037

Lot Numbers:

Product: SPRYSTEP VECTOR KAFO, Custom made device dynamic knee-ankle-foot orthosis

Model / REF:

17VKCUS

17VKCUSX

Lot Numbers:

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93299

Status: Resolved

Manufacturer: Townsend Design

Sold By: Orthotics clinics; Healthcare providers; Authorized distributors

Manufactured In: United States

Units Affected: 3 products (248 units; 898 units; 334 units)