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M-Brace Air

INDACO SRL · Model 45 · UDI-DI 05391512280109

FQM

510(k) clearances

329

Adverse events

Recalls

703

Facilities

Description

The Jumper’s Knee Brace been designed and produced as a support and protective device for tendon and joint inflammations either cause by trauma, stress or excessive fatigue. INDICATIONS : • Apophysitis, patellar chondromalacia, patellofemoral anthralgia, jumper’s knee. • Alleviates pain by diminishing tension on muscles and ligaments. • Could be used as a preventive measure during sports or in a rehab phase. • Swiftly adjustable compression. • Breathable, 100% cotton on your skin.

Recalls

Date	Firm	Reason
2026-02-27	Medline Industries, LP	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2024-04-02	Andover Healthcare Inc.	A packaging seal gap could impact the sterility of the product.
2022-06-22	ASO LLC	The product falls apart during handling after removal from its primary packaging.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-02-01	BSN Medical Inc	The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
2020-08-21	North American Rescue LLC.	Lack of sterility assurance of the 30-0171
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product

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Data 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.