Home › Device types › MBI
Fastener, Fixation, Nondegradable, Soft Tissue
FDA product code MBI · Class 2 · Orthopedic
4,659
Registered devices
25,622
Adverse events
113
Recalls
600
510(k) clearances
Devices with this code
PANALOK ETHIBOND — DEPUY MITEK, LLCGRAVITY — WRIGHT MEDICAL TECHNOLOGY, INC.V-LoX — PARCUS MEDICAL LLCJuggerKnot Soft Anchors — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD — Medos International SàrlArthrex® — ARTHREX, INC.PEEK RCI Screw — SIGNATURE ORTHOPAEDICS PTY LTDHNM SPORTS MEDICINE — HNM STAINLESS, LLC.BIORAPTOR — Smith & Nephew, Inc.GFS II Standard, Large and Mini — PARCUS MEDICAL LLCArthrex® — ARTHREX, INC.PunchTac 4.5mm Anchor — DUNAMIS MEDICAL, LLCFix2Lock — OSTEONIC CO.,Ltd.HEALICOIL — Smith & Nephew, Inc.Helical Ridge — Medshape, Inc.Eclipse — Medshape, Inc.ConMed — Conmed CorporationCUFFLINK Y-KNOT CROSSFT — Conmed CorporationArthrex® — ARTHREX, INC.Kopis Knotless Anchor — MEDLINE INDUSTRIES, INC.Iconix — RIVERPOINT MEDICAL, LLCTitan — MEDLINE INDUSTRIES, INC.MectaScrew PEEK — Medacta International SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Biomet, Inc. | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop |
| 2025-09-09 | Biomet, Inc. | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. |
| 2025-01-29 | Stryker Corporation | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. |
| 2024-10-29 | Smith & Nephew Inc. | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| 2023-10-25 | Riverpoint Medical, LLC | Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may als |
| 2023-08-23 | Stryker Corporation | Expired Product distributed |
| 2023-05-04 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk |
| 2023-05-04 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk |
| 2022-07-13 | Paragon 28, Inc. | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. |
| 2020-11-25 | Biomet, Inc. | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d |
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