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TM "Rehabilitimed" ORTEZ-2V XL-90 Comfort
REABILITIMED TOV · Model ORTEZ-2V XL-90 Comfort · UDI-DI 04823097719954
10
510(k) clearances
102
Adverse events (1 deaths)
6
Recalls
311
Facilities
Description
It is an orthosis for the cervical spine in the form of a fixator made of polyurethane foam base with a height of 90 mm, anatomically shaped, enclosed in a cover made of beige cotton knitted fabric. For fixation, a textile Velcro fastener is sewn on both sides of the orthosis, 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.