SpryStep Vector (Townsend) – Structural Breakage Risk (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR