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Washer, Bolt Nut
FDA product code HTN · Class 2 · Orthopedic
9,569
Registered devices
1,494
Adverse events
4
Recalls
93
510(k) clearances
Devices with this code
NARROW SELF - COMPRESSING PLATE — Biomet Orthopedics, LLCAPTUS — Medartis AGSOLID CANCELLOUS SCREW — Biomet Orthopedics, LLCRONDO' — CITIEFFE SRLTEMPFIX®SPANNING KNEE — Biomet Orthopedics, LLCATN®LAG SCREW — Biomet Orthopedics, LLCVARIAX — Stryker GmbHPER.I.™ IILOCKING CORTICAL SCREW FULL THREAD — Biomet Orthopedics, LLCA.L.P.S.CORTICAL LOCKING SCREW — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.ATN®LAG SCREW — Biomet Orthopedics, LLCVARIAX — Stryker GmbHASNIS — Stryker GmbHASNIS — Stryker GmbHASNIS — Stryker GmbHM.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International SACONMED — Conmed CorporationM.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International SAA.L.P.S.® — Biomet Orthopedics, LLCKyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.A.L.P.S.® — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-22 | TriMed Inc. | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its stre |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2016-08-12 | Arthrex, Inc. | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
| 2013-10-03 | Synthes USA HQ, Inc. | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. |
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