M-Brace Air
INDACO SRL · Model 16 M · UDI-DI 05391512280147
Description
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. 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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