Home › Device types › HTW
Bit, Drill
FDA product code HTW · Class 1 · Orthopedic
0
Registered devices
18,028
Adverse events
114
Recalls
11
510(k) clearances
Devices with this code
EVOS — Smith & Nephew, Inc.Arthrex — ProvisionSumma Orthopaedics System Surgical Instrument — Jeil Medical CorporationDrill bit — Jeil Medical CorporationReprocessed 1.8mm Drill Bit, Quick Coupling, 125mm — SURETEK MEDICALTiger — Trilliant Surgical, LLCArthrex® — ARTHREX, INC.NexGen® — Zimmer, Inc.Syndex with Constrictor® Technology — DUNAMIS MEDICAL, LLCAsnis — Stryker GmbHAsnis — Stryker GmbHNA — Synthes GmbHSumma Orthopaedics System Surgical Instrument — Jeil Medical CorporationPROMOS — Smith & Nephew, Inc.LOCKING CORTICAL TAP — Biomet Orthopedics, LLCNA — STERILMED, INC.Vertex — NVision Biomedical Technologies, Inc.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.NA — WRIGHT MEDICAL TECHNOLOGY, INC.NA — Stryker Leibinger GmbH & Co. KGKYPHON® Introducer Tool Kit — MEDTRONIC SOFAMOR DANEK, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.Arthrex® — ARTHREX, INC.Smith and Nephew — Provision
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-11 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individu |
| 2026-02-11 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individu |
| 2024-01-29 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged" |
| 2024-01-29 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged" |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-07-30 | Paragon 28, Inc. | A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the ca |
| 2021-02-24 | Arthrex, Inc. | The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. |
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