Recall Z-0671-2024— Townsend Design
Class II · Completed
Class II FDA medical device recall by Townsend Design, initiated 2023-09-23. FDA's recall record names no specific 510(k) clearance for this event. Product: SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037. Reason: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis..
- Recalling firm
- Townsend Design
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-09-23
- Firm location
- Bakersfield, CA, United States
Product description
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.