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Turtlebrace

9321-8758 Québec Inc · Model Wrist Pediatric · UDI-DI 20628634832145

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 a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Velcro closure separate. Size medium (02), or large (03), Pediatric (PED)

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.