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Countersink

FDA product code HWW · Class 1 · Orthopedic

396
Registered devices
15
Adverse events
17
Recalls
0
510(k) clearances

Devices with this code

TRIGEN MAX — Smith & Nephew, Inc.Tools-SHD — Trimed, INC.GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS LLCRESORBABLE BONE SCREW — Biomet Orthopedics, LLCHeaded Screw System Instruments — Tyber Medical, LLCORTHOLOC 3DI — WRIGHT MEDICAL TECHNOLOGY, INC.Vilex Tool — VILEX IN TENNESSEE, INC.OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITEDSmith and Nephew — ProvisionStryker — ProvisionN/A — Merete GmbHVERUM System Surgical Instrument — Jeil Medical CorporationGEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS LLCN/A — Merete GmbHNA — aap Implantate AG2.4mm/3.0mm Gridlock Screw Countersink — Trilliant Surgical, LLCVilex Tool — VILEX IN TENNESSEE, INC.DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC.Decima Spine Instrument Kit — DECIMA SPINE, INC.Drill bit — Jeil Medical CorporationDARCO — WRIGHT MEDICAL TECHNOLOGY, INC.DARCO — WRIGHT MEDICAL TECHNOLOGY, INC.Orion Headed Screw System Instruments — Tyber Medical, LLCCOUNTERSINK — Biomet Orthopedics, LLC

Recent recalls

DateFirmReason
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.