M-Brace Air
INDACO SRL · Model 132 R · UDI-DI 05391512281908
Description
This Wrist Support has been designed and produced as a support and protective device for muscular minor damages, as well as for tendon and joint inflammations either caused by light trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension can be adjusted according to individual needs. NON-ELASTIC. Patented M-Brace technology. INDICATIONS • For light traumas and minor injuries of the wrist. • Post-trauma rehab and prevention during sports. Easily adjustable compression. • 100% breathable. • Patented M-Brace technology. • Neoprene and latex free.
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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