Home › Device types › HTW
Bit, Drill
FDA product code HTW · Class 1 · Orthopedic
10,845
Registered devices
17,754
Adverse events
114
Recalls
11
510(k) clearances
Devices with this code
Acumed — ProvisionSECURESPAN — Aesculap AGNA — Synthes GmbHNA — Synthes GmbHVilex Drill Cannulated — VILEX LLCGENERIC Surgical Instruments — CTL Medical CorporationNA — aap Implantate AGZuma-C — Seaspine Orthopedics CorporationMemoFix® Super Elastic Nitinol Staple System — Ascension Orthopedics, Inc.EMERGE MEDICAL & Design — EMERGE MEDICAL, INC.Vanguard® — Biomet Orthopedics, LLCFlower Orthopedics — FLOWER ORTHOPEDICS CORPORATIONNovo Surgical Inc. — NOVO SURGICAL, INC.TRIGEN MAX — Smith & Nephew, Inc.DRILL BIT — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.STABOLT — MEDICREA INTERNATIONALStryker — ProvisionSumma Orthopaedics System Surgical Instrument — Jeil Medical Corporation4.7MM CANNULATED DRILL — Biomet Orthopedics, LLCNA — STERILMED, INC.Brasseler — ProvisionInsignia — ALPHATEC SPINE, INC.Tandry Orthopedic Manual Surgical Instrument — MICROWARE PRECISION CO., LTD.
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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