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Turtlebrace

9321-8758 Québec Inc · Model Ankle Baby · UDI-DI 10628634832018

IQI Prescription

510(k) clearances

456

Adverse events (2 deaths)

Recalls

519

Facilities

Description

The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03) for Baby (BB)

Recalls

Date	Firm	Reason
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2018-01-31	3M Company - Health Care Business	3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur
2018-01-31	3M Company - Health Care Business	3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur
2016-11-07	DeRoyal Industries Inc	DeRoyal received complaints of mold on Tennis Elbow Straps.
2016-11-07	DeRoyal Industries Inc	DeRoyal received complaints of mold on Tennis Elbow Straps.
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.