Joint, Knee, External Brace
Physical Medicine · 21 CFR 890.3475
Recent MDR events
489 adverse event reports on file
- DONJOYJul 14, 2026InjuryDjo Llc9616086-2026-00026
- DONJOY ECONOMY WRAP AROUND HINGEMay 20, 2026MalfunctionDjo, Llc25229068
- FREE WALKMay 13, 2026InjuryOttobock Se & Co. Kgaa9616494-2026-00002
- DRYTEX ECONOMY HINGE KNEE, WRAP, POP, XSMay 6, 2026MalfunctionDjo, Llc25092930
- PROCAREApr 24, 2026InjuryDjo Llc9616086-2026-00015
- DONJOYApr 24, 2026InjuryDjo Llc9616086-2026-00019
- DONJOY DRYTEX ECONOMY HINGED KNEE BRACEMar 17, 2026MalfunctionDjo, Llc24616759
- DONJOY TELESCOPING TROM ADVANCE COOLJan 8, 2026MalfunctionDjo, Llc24003007
- C-BRACE JOINT UNITDec 5, 2025InjuryOtto Bock Healthcare Products Gmbh9615892-2025-00017
- CORETECH ROM KNEE IMOBILIZERNov 14, 2025InjuryVive Health Llc23553689
Event type breakdown
Recalls
12 recall events for this product code
- United Surgical AssociatesTerminatedMay 23, 2015
Elastic Knee Support.
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Z-1665-2015 · View FDA record ↗ - De Royal IndustriesTerminatedMar 19, 2003
Flexgard, off-the-shelf knee brace, product number 14761106
Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
Z-0658-03 · View FDA record ↗ - CorflexTerminatedUnknown
Corflex Contender Post-Op Knee Brace Lite
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0574-2016 · View FDA record ↗ - CorflexTerminatedUnknown
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0575-2016 · View FDA record ↗ - CorflexTerminatedUnknown
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0576-2016 · View FDA record ↗ - CorflexTerminatedUnknown
ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0577-2016 · View FDA record ↗ - CorflexTerminatedUnknown
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0578-2016 · View FDA record ↗ - CorflexTerminatedUnknown
ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0579-2016 · View FDA record ↗ - CorflexTerminatedUnknown
CONTENDER POST-OP-KNEE BRACE FULL FOAM
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Z-0580-2016 · View FDA record ↗ - DeRoyal Industries IncOpen, ClassifiedUnknown
DeRoyal KNEE BRACE, WARRIOR RECOVERY:
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Z-0706-2020 · View FDA record ↗
Registered firms
454 firms currently registered for this product code
F.g.p. S.r.l.
DOSSOBUONO Verona, IT
Pantymed S.a.
BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
Jasan International Limited
Hong Kong, HK
Dongguan Sinohome Limited
Dongguan City Guangdong, CN
Kinetec Usa
Jackson, WI, US
Yangzhou Feiyali Sporting Goods Co.ltd
Yangzhou Jiangsu, CN
R&r Medical Corporation Ltd.
Sanchong District New Taipei, TW
Barbaras Development, Inc.
Thousand Oaks, CA, US
Pavis S.p.a.
Buguggiate Varese, IT
Weiguo Solutions Limited
Zhuhai Guangdong, CN
American Medical Products Llc
Eatontown, NJ, US
Ipe Plastic & Hardware Industy, Ltd
Dongguan Guangdong, CN
Abletech Orthopedics Corporation
New Taipei City Taiwan, CN
Bms Co.,ltd
Paju Gyeonggi, KR
Yangzhou Zhilin Sports Items Co., Ltd
Yangzhou Jiangsu, CN
Rival Vietnam Co.,ltd
HUNG YEN PROVINCE, VN
Incrediwear Holdings, Inc.
Chico, CA, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Fourstar Group Inc.
TAIPEI, TW
Yearstar Healthcare Technology Co.,ltd
JIANGYIN Jiangsu, CN
Medi Mfg., Inc.
WHITSETT, NC, US
Top Longmax Products Co., Ltd.
TAICHUNG, TW
Fillauer, Llc
CHATTANOOGA, TN, US
Dms Holdings, Inc.,
Waukegan, IL, US
Alps Xiangtan Prosthetic & Orthotic Co., Ltd.
XIANGTAN, HUNAN, CN
510(k) clearances
15 clearances for this product code
- Orthopedic Systems, Inc.Jun 24, 1983
K831044 · LIMITED MOTION FUNCTIONAL KNEE BRACE
- Innovation Sports, Inc.May 16, 1983
K831310 · BRACE C.T.
- Warm & Form, Orthopedic MaterialsDec 30, 1982
K823658 · DELUXE KNEE IMMOBILIZER(UNIVERSAL)
- Orthopedic Systems, Inc.Nov 29, 1982
K823397 · ANATOMIC FRACTURE BRACE
- Warm & Form, Orthopedic MaterialsNov 10, 1982
K823159 · DELUXE KNEE IMMOBILIZER
- Surgical Appliance Industries, Inc.Sep 14, 1981
K812423 · NEOPRENE KNEE SUPPORT
- Aircast, Inc.Aug 13, 1981
K812094 · AIRCAST PNEUMATIC KNEE BRACE
- Surgical Appliance Industries, Inc.Jun 25, 1981
K811689 · CYLINDER KNEE CAST/SPLINT