RAPHAEL 25 Instrument Kit
OTS MEDICAL LTD · Model 100-606 · UDI-DI 07290019507079
Description
Raphael 25 is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene. The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.
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 also move off the drill |
| 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 to patients include |
| 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 to patients include |
| 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 device. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs