Device recall: Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lo
United Surgical Associates (Fort Wayne, IN) initiated this device recall on 13 Apr 2015; FDA lists 3 product records under event 71256, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Jul 2015. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for United Surgical Associates.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
United Surgical Associates, Fort Wayne, IN.
Reason for recall
"The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction"
Distribution
"Domestic: HI International; None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1664-2015 | Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | 1278 | Class II | Terminated | 3 Jun 2015 |
| Z-1665-2015 | Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | 1260 | Class II | Terminated | 3 Jun 2015 |
| Z-1666-2015 | Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | 756 | Class II | Terminated | 3 Jun 2015 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic: HI International; None"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.