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TM "Rehabilitimed" ORTEZ-2V-1 XL-110 Comfort
REABILITIMED TOV · Model ORTEZ-2V-1 XL-110 Comfort · UDI-DI 04823097719787
10
510(k) clearances
100
Adverse events (1 deaths)
6
Recalls
311
Facilities
Description
It is an orthosis for the cervical spine in the form of an anatomically shaped base made of foamed polyethylene 110 mm high, which has the necessary density and elasticity, and a cover made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) of beige color. On both sides of the orthosis, a textile fastener is sewn, which allows you to more accurately fix the product around the neck.
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.