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U.S. Department of Health and Human Services

Class 2 Device Recall SPRYSTEP VECTOR KAFO, Custom made device dynamic KAFO non locking

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  Class 2 Device Recall SPRYSTEP VECTOR KAFO, Custom made device dynamic KAFO non locking see related information
Date Initiated by Firm September 23, 2023
Date Posted January 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-0672-2024
Recall Event ID 93299
Product Classification Orthosis, limb brace - Product Code IQI
Product SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Code Information REF: 17VKCUS:UDI: /Order #s: 868003 864980 877514 867899 875411 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 870222 869927 873860 873860 865503 878668 878182 863772 866842 878791 865507 863707 872687 868289 873685 870922 870922 864367 865966 875463 871512 871512 870916 866919 879216 878252 879014 874428 867045 878412 863471 871544 874438 872200 870646 872512 865508 865508 876593 869370 865720 863470 876045 867371 865737 868736 873157 867694 875149 867457 875554 863353 867286 873781 873357 867357 873861 871137 REF: 17VKCUSX: UDI:/Order #s: 873093 877251 877251 864343 864343 876329 867359 867359 876421 867376 868295 863890 873575 868834 874561 874561 877602 877602 872207 872835 864342 867052 874879 878550 865056 865056 879221 877567 882074 871827 871827 865201 877909 877909 869372 869374 866576 867687 874242 876221 876221 874239 877527 868310 864590 872312 872312 874217 874217 875682 875682 875682 875682 865743 864949 864949 864960 872833 872535 872535 870881 870881 875053 875053 877459 866653 876099 870214 873791 873025 863340 866810 868042 868534 869716 871539 874028 877634 865745 876675 872003 873863 874082 875898 873401 878664 871403 872028 865207 870243 873579 874453 874453 867886 878116 867382 871008 878134 865464 865464 867932 872463 872463 876902 876902 868831 869045 867147 865504 872823 871992 875377 871991 877676 877676 867685 866669 864414 879749 874886 868285 877400 851811 872744 867952 874200 879006 863770 867434 868553 868553 872288 878683 870549 870549 880814 869364 869364 873639 866843 866843 874962 867157 874203 877228 869368 877671 865110 877397 876724 876724 868568 874257 879001 869360 874434 865199 869355 869357 872782 872782 876495 878215 867953 877996 877996 865741 873810 877262 877262 866658 869190 865352 866846 866846 877116 877116 869120 881824 872223 868495 868495 879817 877705 868571 864955 869325 872022 876058 876506 865502 867369 871309 877674 873159 865734 874271 873186 873186 877902 871616 875378 879484 871718 873403 877625 877625 868835 872314 866526 866598 867787 868609 872580 872926 873740 873740 874952 875239 875239 878620 878914 867143 878743 875178 873923 870027 877741 867148 870660 877200 865435 864078 879739 877273 878832 878832 873169 865102 874535
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 334 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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