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U.S. Department of Health and Human Services

Class 2 Device Recall CUSTOM SPRYSTEP, custom made device dynamic AFOf

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  Class 2 Device Recall CUSTOM SPRYSTEP, custom made device dynamic AFOf see related information
Date Initiated by Firm September 23, 2023
Date Posted January 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-0670-2024
Recall Event ID 93299
Product Classification Orthosis, limb brace - Product Code IQI
Product CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis
(AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
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;
Recalling Firm/
Manufacturer		 Townsend Design
4615 Shepard St
Bakersfield CA 93313-2339
For Additional Information Contact Veronica Salazar
800-432-3466
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On November 7, 2023, Townsend Design (Thuasne USA), issued a "Urgent Medical Device Recall notification to affected consignees: Townsend Design asked consignees to take the following actions: 1. Clinician should contact any patient who was fit with a device received between June 14th and September 10, 2023 to notify them of the recall and schedule a visit to examine the patient's device. 2. During the patient visit, the clinician should examine the device for structural defects (delamination, cracking, complete breakage, etc.) in the area identified in the picture above in Section 3 3. If the device is observed with a defect, patient should immediately discontinue use of the device and it should be returned to Townsend Design (Thuasne USA) 4. Clinician can contact Townsend Design (Thuasne USA) Customer Service at 800-432-3466 for return and replacement instructions 5. Townsend Design (Thuasne USA) will either refund or replace the product 6. Clinician to complete and return the attached Acknowledgement and Receipt Form within 5 working days
Quantity in Commerce 248 units
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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