Orthosis, Limb Brace
Physical Medicine · 21 CFR 890.3475
Recent MDR events
456 adverse event reports on file
- AIRCASTJul 21, 2026InjuryDjo, Llc.MW5190947
- MEDLINEMar 10, 2026InjuryMedline Industries Lp1417592-2026-00204
- CERVICAL COLLARFeb 17, 2026MalfunctionBreg, Inc.MW5183931
- PROCARE 20" UNIV BASIC KNEE SPLINTJan 8, 2026MalfunctionDjo Llc24003605
- FEMUR FRACTURE BRACEDec 12, 2025MalfunctionOrthopediatrics3006460162-2025-00079
- FEMUR FRACTURE BRACEDec 12, 2025MalfunctionOrthopediatrics3006460162-2025-00080
- EXOSNov 7, 2025InjuryDjo Llc9616086-2025-00069
- DF2 FEMUR FRACTURE BRACEAug 6, 2025MalfunctionOrthopediatrics, Corp3006460162-2025-00043
- MOLDING CAST / ARIZONA AFOMar 26, 2025InjuryThe Orthotic Group, Inc.MW5168257
- CUSTOM ORTHOTICSJan 22, 2025InjuryForward Motion Medical SystemsMW5165135
Event type breakdown
Recalls
17 recall events for this product code
- Townsend DesignCompletedJan 5, 2024
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Z-0670-2024 · View FDA record ↗ - Townsend DesignCompletedJan 5, 2024
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Z-0671-2024 · View FDA record ↗ - Townsend DesignCompletedJan 5, 2024
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Z-0672-2024 · View FDA record ↗ - United Surgical AssociatesTerminatedMay 23, 2015
Keo Brace, elastic wrist brace for carpal tunnel.
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Z-1666-2015 · View FDA record ↗ - Breg IncTerminatedApr 10, 2014
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415.
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Z-1446-2014 · View FDA record ↗ - Breg IncTerminatedApr 10, 2014
K-Lite Knee 2 Stays with Visco, Model No. 122015.
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Z-1447-2014 · View FDA record ↗ - DeRoyal Industries IncTerminatedUnknown
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only,
DeRoyal received complaints of mold on Tennis Elbow Straps.
Z-0712-2017 · View FDA record ↗ - DeRoyal Industries IncTerminatedUnknown
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,
DeRoyal received complaints of mold on Tennis Elbow Straps.
Z-0713-2017 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedUnknown
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
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 natural latex rubber, but do not include the appropriate caution statement.
Z-0945-2018 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedUnknown
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
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 natural latex rubber, but do not include the appropriate caution statement.
Z-0946-2018 · View FDA record ↗
Registered firms
521 firms currently registered for this product code
Shijiazhuang Aofeite Medical Device Co.,ltd
Shijiazhuang Hebei, CN
Bort Gmbh
WEINSTADT-BENZACH Baden-Wurttemberg, DE
Zhangpu Ortholife Rehabilitation Co., Ltd
Zhangzhou Fujian, CN
Zhejiang Rongrong Hosiery Co Ltd
Yiwu Zhejiang, CN
Pure Medical Inc.
Wauwatosa, WI, US
Her Sheng Footwear Co., Ltd.
GUANGZHOU Guangdong, CN
Dela Incorporated
Ward Hill, MA, US
Huntex Corporation
TAIPEI, TW
Thuasne, Llc
BAKERSFIELD, CA, US
Djo, Llc
Vista, CA, US
Surestep, Llc
South Bend, IN, US
Precision Medical Products
Rocklin, CA, US
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
Acot Plastics (xiamen) Co., Ltd.
XIAMEN Fujian, CN
Md Orthopaedics
Wayland, IA, US
Sdrh Inc
Brooklyn, NY, US
Zhejiang Steriger Sports Medicine Technology Co.,ltd
Yiwu Zhejiang, CN
Tidi Products, Llc
NEENAH, WI, US
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi
Salihli Manisa, TR
Pinta Elements
Minneapolis, MN, US
Ossur Europe B.v.
Eindhoven Noord-Brabant, NL
Ceva Logistics Netherlands B.v.
Oostrum Limburg, NL
Varitronics
BROOMALL, PA, US
John Sheng Enterprise Co., Ltd
TAICHUNG City, TW
P.c.p. Champion
RIPLEY, OH, US
510(k) clearances
52 clearances for this product code
- Neurospectrum, LLCAug 13, 2015
K143458 · Neurosplint
- Otto Bock Healthcare LPMay 3, 2006
K052771 · SENSOR WALK
- Surgitech, Inc.Jul 31, 2003
K031576 · SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
- Regulatory & Marketing Services, Inc.Jul 22, 1993
K926391 · ACCUFLEX DYNAMIC ELBOW ORTHOSIS
- Mcconnell OrthopedicMar 21, 1991
K910974 · MCCONNELL SHOULDER BRACE
- Gait-Aid, Inc.Nov 30, 1987
K874502 · GAIT-AID ORTHOPEDIC INSOLE
- Fred Sammons, Inc.Jun 24, 1983
K831542 · ADJUSTABLE POLYCENTRIC ELBOW HINGE
- Edward Dilauro, Jr.Jun 15, 1983
K831615 · DROP FOOT BRACE