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MaxBraid Suture BroadBand Tape (Ultra)
RIVERPOINT MEDICAL, LLC · Model 110046455 · UDI-DI 00840277401397
0
510(k) clearances
40
Adverse events
10
Recalls
34
Facilities
Description
Subscapularis Repair Suture Kit-Ultra (Suture Kit - KIT701 is convenience kit containing HS Fiber sutures (K190817) and Drill Bit (HTW, 510k exempt)).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-09 | LSL Healthcare Inc. | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. |
| 2025-12-12 | Medline Industries, LP | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via |
| 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 |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| 2014-06-12 | Medical Action Industries Inc | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
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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.