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Countersink

FDA product code HWW · Class 1 · Orthopedic

416
Registered devices
15
Adverse events
17
Recalls
0
510(k) clearances

Devices with this code

NA — Synthes GmbHCountersink — CURVAFIX, INC.NA — Synthes GmbHNA — aap Implantate AGAmbler Surgical — AMBLER SURGICAL CORP.OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITEDVilex Jones Fracture Tool — VILEX IN TENNESSEE, INC.FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTDDrill bit — Jeil Medical CorporationNA — aap Implantate AGInion® Universal instruments — Inion OygSource — GSOURCE LLCMade-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC.Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC.Stryker — ProvisionLEOS Cannulated Screw System — Tyber Medical, LLCBIODRIVE CANNULATED SCREW SYS — Biomet Orthopedics, LLCORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITEDEVOLVE — WRIGHT MEDICAL TECHNOLOGY, INC.DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC.GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS LLCCARDINAL HEALTH — Cardinal Health 200, LLCVilex Jones Fracture Tool — VILEX IN TENNESSEE, INC.GEO Bone Screw System — GRAMERCY EXTREMITY 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.