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MEDI MANUFACTURING, INC. · Model PIA0245 · UDI-DI 04049772344482
10
510(k) clearances
456
Adverse events (2 deaths)
17
Recalls
519
Facilities
Description
COMFORT PRO - E 45, MEN 11-11.5, WOMEN -
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 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.