SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17

FDA device recall Z-0671-2024 · posted 2024-01-05 · Completed

Recall details

Recalling firm

Townsend Design

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.

Action taken

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

Root cause

Process control

Status

Completed

Product code

IQI

Quantity affected

898 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 Zealan

Date initiated

2023-09-23

Date posted

2024-01-05

Location

Bakersfield, CA