Joint, Ankle, External Brace
Physical Medicine · 21 CFR 890.3475
Recent MDR events
70 adverse event reports on file
- THERAPEUTIC BOOTJan 12, 2026InjuryBreg, Inc.MW5182037
- UNITED ORTHO AIR CAM WALKER FRACTURE BOOTNov 5, 2025InjuryUnited Surgical Llc/united OrthoMW5178543
- ANKLE SUPPORT,ADJUSTABLE ANKLE BRACE BREATHABLE NYLON MATERIAL SUPER ELASTIC ANDOct 28, 2024InjuryUnknownMW5161773
- PLANTAR FASCIITIS NIGHT SPLINT SOCKS, LARGEOct 2, 2024InjuryComforce Co.ltdMW5160471
- REBOUND AIR WALKERApr 10, 2024InjuryOssur AmericasMW5153728
- UNK TIBIAL INSERT COMPONENTAug 4, 2020InjuryZimmer Biomet, Inc.0001822565-2020-02808
- UNKNOWN TM ANKLE PRODUCTSAug 3, 2020InjuryZimmer Biomet, Inc.0001822565-2020-02735
- AIRCAST A60 ANKLE BRACE,L,RTOct 21, 2019MalfunctionDjo, Llc9616086-2019-00074
- PROTECTOR, HEEL, HEEL RAISER, OSFMOct 16, 2019InjuryMedline Industries Inc.1417592-2019-00167
- AIRCAST SP-WALKER, MEDIUMJul 29, 2019MalfunctionDjo, Llc9616086-2019-00051
Event type breakdown
Recalls
3 recall events for this product code
- United Surgical AssociatesTerminatedMay 23, 2015
Elastic Ankle Support.
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Z-1664-2015 · View FDA record ↗ - Ossur H / FTerminatedUnknown
Rebound Air Walker
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Z-1291-2016 · View FDA record ↗ - Ossur H / FTerminatedUnknown
Rebound Diabetic Walker
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Z-1292-2016 · View FDA record ↗
Registered firms
461 firms currently registered for this product code
Suzhou Sunmed Co., Ltd
SUZHOU CITY Jiangsu, CN
Dongguan Nan You Sporting Goods Enterprise Ltd
Dongguan Guangdong, CN
Tommie Copper Inc
Mount Kisco, NY, US
Power Well Healthcare Technology Co., Ltd.
Changhua County, TW
Le Shin International Co., Ltd.
Kaohsiung,, TW
Edser Insoles S.l.
ESPLUGUES DE LLOBREGAT Barcelona, ES
Incrediwear Holdings, Inc.
Chico, CA, US
Pantymed S.a.
BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
Jiundar Industrial Co., Ltd.
SHULIN CITY Taipei, TW
Aider Inc.
Gangseo-gu Seoul, KR
Djo Tunisie
SFAX, TN
Zhejiang Longmed Medical Technology Co., Ltd.
Huzhou Zhejiang, CN
Zhangzhou Recaring Medical Instrument Co., Ltd
Zhangzhou Fujian, CN
Airway Surgical Appliances Ltd.
NEPEAN Ontario, CA
Dawn Breeze Int'l Trading Limited
Wan Chai Hong Kong, CN
U.s. Orthotics, Inc.
Tampa, FL, US
Advanced Orthopaedics, Llc
Bloomsburg, PA, US
Kobayashi Pharmaceutical (china) Co.,ltd.
Minhang District Shanghai, CN
Vitaform, Inc.
Dana Point, CA, US
Planet(shanghai) International Co.,ltd
shanghai, CN
Fillauer, Llc
CHATTANOOGA, TN, US
Yangzhou Haiwang Toothbrush Factory
Yangzhou Jiangsu, CN
Thuasne, Llc
Chihuahua, MX
Tecma Operaciones S. De R.l. De C.v.
Juarez Chihuahua, MX
Hausmann Enterprises, Llc
NORTHVALE, NJ, US
510(k) clearances
1 clearances for this product code