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Lightning X Products, Inc
XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Model COL007 · UDI-DI 06946430425072
10
510(k) clearances
102
Adverse events (1 deaths)
6
Recalls
314
Facilities
Description
The collar is a one-piece rigid cervical spine immobilization device designed to assist the rescuer with the maintenance of neutral alignment, prevention of lateral (side-to-side) sway and anterior-posterior (forward and backward) flexion and extension of the cervical spine during patient transport or movement.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-20 | Ossur H / F | 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 peel |
| 2021-11-09 | Ossur Americas | Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. |
| 2021-06-01 | Ossur Americas | 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 incr |
| 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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Get your free API keyRead the docsData 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.