Home › Device types › HWC
Screw, Fixation, Bone
FDA product code HWC · Class 2 · Orthopedic
133,412
Registered devices
58,622
Adverse events
388
Recalls
1,063
510(k) clearances
Devices with this code
FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLCFuzeFix Max FT — FUSION ORTHOPEDICS, LLCGMReis Ankle Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDAAUTOBAHN — GLOBUS MEDICAL, INC.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.PRO-TOE — WRIGHT MEDICAL TECHNOLOGY, INC.Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDAORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC.OSSIOfiber® Threaded Trimmable Fixation Nail — OSSIO LTDDART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC.Locking Proximal Femur Plate System — ORTHOPEDIATRICS CORP.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.Vilex Dual Thread Screw — VILEX LLCVilex Dual Thread Screw — VILEX LLCAXSOS — Stryker GmbHSYNDESMOSIS SCREW — INTRAUMA SPAINSTRUMENT — Howmedica Osteonics Corp.OTIS-C PLUS — S.B.MINSTRUMENT — Howmedica Osteonics Corp.IMN Screws — Stryker GmbHCrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMSLong Cannulated Screw System — WRIGHT MEDICAL TECHNOLOGY, INC.Super Upper Limbs Versalock Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDAMicroware Bone Plates and Bone Screws — MICROWARE PRECISION CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza |
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