Home › Device types › MBI
Fastener, Fixation, Nondegradable, Soft Tissue
FDA product code MBI · Class 2 · Orthopedic
4,740
Registered devices
26,348
Adverse events
113
Recalls
604
510(k) clearances
Devices with this code
RIGIDLOOP — S.B.MArthrex® — ARTHREX, INC.JUGGERLOC 5MM SLOTTED REAMER — Biomet Orthopedics, LLCQuattro® — CAYENNE MEDICAL, INC.Syndex with Constrictor® Technology — DUNAMIS MEDICAL, LLCORTHOBUTTON CL — RIVERPOINT MEDICAL, LLCArthrex® — ARTHREX, INC.GMReis Suture Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDATritis — Covidien LPMULTIFIX — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.Wire for screw TLS D 1,8 LG 220mm — FOURNITURES HOSPITALIERES INDUSTRIEArthrex® — ARTHREX, INC.INTRAFIX — Medos International SàrlArthrex® — ARTHREX, INC.JuggerKnot Soft Anchor — RIVERPOINT MEDICAL, LLCFix2Lock — OSTEONIC CO.,Ltd.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.VersiTILT Drill Pin, 3.1mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONSlik Fix Screw — PARCUS MEDICAL LLCCRP™ Cuff Repair Plate System — Shoulder Options, Inc.GENIE PEEK/Bio Knotless Anchor — OSTEONIC CO.,Ltd.Integrity Orthopaedics — Integrity Orthopaedics, Inc
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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