Recall Z-0670-2024— 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: CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040. 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
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
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.