Orthosis, Cervical
Physical Medicine · 21 CFR 890.3490
Recent MDR events
100 adverse event reports on file
- MIAMI J SELECTOct 30, 2025InjuryOssur3003764610-2025-00009
- MIAMI J SELECT COLLAR SETOct 1, 2025InjuryOssur Americas23187757
- OTTOBOCK 50C80=MINERVA ORTHOSISAug 5, 2025DeathOtto Bock Healthcare LpMW5173991
- MIAMI J SELECT COLLAR SETJul 16, 2025MalfunctionOssur Americas22519411
- AMBU PERFIT ACE COLLARApr 4, 2025MalfunctionAmbu A/s9610691-2025-00003
- AMBU PERFIT ACE COLLARApr 4, 2025MalfunctionAmbu A/s1220828-2025-00003
- STIFNECK SELECT EXTRICATION COLLARJul 22, 2024InjuryLaerdal Medical As3004993040-2024-00001
- CERVICAL COLLAR, EMT SELECT, ONE PIECE, ADULT UNIVMar 18, 2024MalfunctionDeroyal Intercontinental, S.r.l3004605321-2024-00001
- EMT SELECT EXTRICATION COLLARFeb 2, 2024MalfunctionDeroyal Industries, Inc.MW5151053
- VISTA CTOMay 2, 2023MalfunctionAspen Medical Products, Llc16852689
Event type breakdown
Recalls
6 recall events for this product code
- Ossur H / FOpen, ClassifiedOct 1, 2024
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Z-0006-2025 · View FDA record ↗ - Ossur AmericasTerminatedUnknown
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Z-0380-2022 · View FDA record ↗ - Ossur H / FTerminatedUnknown
NecLoc Extrication Collar
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-1287-2016 · View FDA record ↗ - Ossur H / FTerminatedUnknown
Miami J Collar
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-1288-2016 · View FDA record ↗ - Ossur H / FTerminatedUnknown
Papoose Infant Spine Immobilizer
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-1298-2016 · View FDA record ↗ - Ossur AmericasTerminatedUnknown
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine.
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
Z-1896-2021 · View FDA record ↗
Registered firms
312 firms currently registered for this product code
Laerdal Medical (suzhou) Co., Ltd.
215009 SUZHOU JIANGSU PROVINCE, CN
Depuy Spine, Inc.
RAYNHAM, MA, US
U.s. Orthotics, Inc.
Tampa, FL, US
Jiangxi Boying Industrial Co., Ltd
YiChun City Jiangxi, CN
Airway Surgical Appliances Ltd.
NEPEAN Ontario, CA
Orthomerica Products, Inc.
ORLANDO, FL, US
Hebei Dingli Medical Apparatus And Instrument Co., Ltd
HENGSHUI CITY Hebei, CN
Relief Medical
Phoenix, AZ, US
Xiamen J-brace Medical Equipment Co., Ltd.
Xiamen Fujian, CN
Anji Spenq Industrial Co., Ltd.
Huzhou Zhejiang, CN
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Yiwu Ori-power Medtech Co., Ltd.
YIWU Zhejiang, CN
Yangzhou Feiyali Sporting Goods Co.ltd
Yangzhou Jiangsu, CN
Essity Distribution B.v.
GE Oostrum Fryslan, NL
Mammon International Corp.
TAIPEI CITY, TW
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Ipe Plastic & Hardware Industy, Ltd
Dongguan Guangdong, CN
Variteks Ortopedi Sanayi A.s.
Catalca Istanbul, TR
Shenzhen Tsingyan Health Technology Co., Ltd.
Shenzhen Guangdong, CN
Air A Med, Llc
Fort Myers, FL, US
Zhangzhou Recaring Medical Instrument Co., Ltd
Zhangzhou Fujian, CN
Hefei Baoguo Information Technology Co., Ltd
Hefei Anhui, CN
Dongguan Park Sport Products Co., Ltd.
Dongguan Guangdong, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Drtv Asia Ltd
Panyu GuangZhou Guangdong, CN
510(k) clearances
27 clearances for this product code
- The Western Diagnostics Co.Jul 22, 1993
K930730 · DORMIE NECK SUPPORT SYSTEM
- Medical Emergency Support EquipmentMar 30, 1993
K926291 · SCHUL-TEC IMMOBILIZER
- Nova Health Systems, Inc.Jan 10, 1990
K895477 · NOVA PILLOW
- Keystone Veterinary Supplies, Inc.Jan 10, 1990
K896042 · MEDICAL DISPOSABLE BEDDING
- Battle Creek Equipment Co.Aug 9, 1988
K882264 · BATTLE CREEK PILLOW
- Abco Dealers, Inc.Apr 25, 1985
K850465 · CERVICAL COLLARS & HEAD HALTERS
- Laerdal California, Inc.Nov 7, 1983
K832990 · STIFNICK IMMOBILIZING COLLAR
- Int'L Safety Corp.Jul 12, 1983
K832001 · HEAD-IMMOBILIZER