Recall Z-0670-2024 ยท IQI Orthosis, Limb Brace
Townsend Design
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
| Date | Jan 5, 2024 (initiated Sep 23, 2023) |
| Status | Completed |
| Reason | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| Root cause | 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 |
| Quantity | 248 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.