CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000...
FDA Device Recall #Z-0670-2024 — Class II — September 23, 2023
Recall Summary
| Recall Number | Z-0670-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 23, 2023 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Townsend Design |
| Location | Bakersfield, CA |
| Product Type | Devices |
| Quantity | 248 units |
Product Description
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
Reason for Recall
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Distribution Pattern
US: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom
Lot / Code Information
REF: 17C1000: UDI: (01)04035459406987/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; REF:17C2000: UDI: (01)04035459406970/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; REF: 17C1010: UDI: (01)04035459407021/Order #s: 870369 881820 874040 879520 876180 870245 876186 871950 867672 878203 879246 880392 867984 879241 869603 877984 868694 876481 872772 869860 872009 869189 877643 874640 880427 867373 872516 869542 877296 870860 877502 867305 879052 878973 881513 865708 873091 879253; REF:17C2010: UDI: (01)04035459407014/Order #s: 868833 881820 877376 874040 879520 876180 869636 876186 869607 867672 878203 879246 880212 867984 869391 878893 875114 881605 868694 874706 869860 877648 874640 867373 867171 872516 877296 870860 877502 867305 879052 873091 879253 874211; REF:17C1040: UDI: (01)04035459407007/Order #s: 871643 871906 878303 869612 872321 872024 874230 876323 880348 878814 878816 871550 875852 880935 879597 880879 881558 875414 879602 880582 869590 869377 869013 872941 871638 870777; REF:17C2040:UDI: (01)04035459406994/Order #s: 871407 878303 874794 872024 877715 867407 868726 880348 878814 878816 873386 877977 870640 878844 875126 880315 871164 881558 878181 870868 869377 869389 869013 870919 870777 868615 871970 875970;
Other Recalls from Townsend Design
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0672-2024 | Class II | SPRYSTEP VECTOR KAFO, Custom made device dynami... | Sep 23, 2023 |
| Z-0671-2024 | Class II | SPRYSTEP VECTOR, Custom made device dynamic ank... | Sep 23, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.