Bit, Drill
FDA product code HTW · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
11510(k) clearances
0PMA approvals
107recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill BitHTW · Traditional | Renovo Life, LLC | 01/15/2016SE |
| K942906 | Agee-Wristjack Pre-Drill KitHTW · Traditional | Hand Biomechanics Lab, Inc. | 12/22/1994SE |
| K930339 | Reamer BitHTW · Traditional | Neoligaments, Ltd. | 08/06/1993SE |
| K915692 | Cannulated Drill BitHTW · Traditional | W. L. Gore & Associates, Inc. | 01/16/1992SE |
| K892903 | Mitek Anchor DrillHTW · Traditional | Mitek Surgical Products, Inc. | 10/06/1989SE |
| K870217 | Femoral Cement Removal InstrumentsHTW · Traditional | Kenneth J. Hoek, M.D., Inc. | 02/06/1987SE |
| K863147 | Glenoid DrillHTW · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K841629 | Drill BitHTW · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K834229 | Bone Plugging ToolHTW · Traditional | Standard Surgical | 01/10/1984SE |
| K831712 | Surgical Drill BitsHTW · Traditional | Medical Specialists IN Packaging | 07/07/1983SE |
| K820226 | Universall Drill GuideHTW · Traditional | Ortho Pared Instruments, Inc. | 02/04/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1652-2026 Class II | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in… | Waldemar Link GmbH & Co. KG (Mfg Site) | 02/11/2026Open, Classified |
| Z-1651-2026 Class II | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in… | Waldemar Link GmbH & Co. KG (Mfg Site) | 02/11/2026Open, Classified |
| Z-1258-2024 Class II | Embrace Drill Tower, Standard/Lateral (25mm)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63)… | Waldemar Link GmbH & Co. KG (Mfg Site) | 01/29/2024Open, Classified |
| Z-1257-2024 Class II | Embrace Drill Tower, Wedged (25mm)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63)… | Waldemar Link GmbH & Co. KG (Mfg Site) | 01/29/2024Open, Classified |
| Z-0114-2022 Class II | Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used…Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Flower Orthopedics Corporation | 09/01/2021Terminated |
| Z-0113-2022 Class II | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used…Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Flower Orthopedics Corporation | 09/01/2021Terminated |
| Z-0112-2022 Class II | Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used…Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Flower Orthopedics Corporation | 09/01/2021Terminated |
| Z-0111-2022 Class II | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be…Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Flower Orthopedics Corporation | 09/01/2021Terminated |
| Z-2488-2021 Class II | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630A thin wall condition between the inner cannulation and the flutes of the drill which potentially could… | Paragon 28, Inc. | 07/30/2021Terminated |
| Z-1310-2021 Class II | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and…The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. | Arthrex, Inc. | 02/24/2021Terminated |
| Z-0631-2021 Class II | RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-2236-2021 Class II | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use…Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to… | Neosteo | 11/03/2020Terminated |
| Z-1892-2020 Class II | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI:…Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This… | Trilliant Surgical, LLC | 10/10/2019Terminated |
| Z-1486-2019 Class II | Drill, contra-angle, 1.5x85mm, Item Number ST502015706An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1485-2019 Class II | Drill, 3.2x145mm, AO, Item Number ST502015650An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1484-2019 Class II | Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1483-2019 Class II | Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1482-2019 Class II | Drill, cannulated, 3x90mm, AO, Item Number ST502015631An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1481-2019 Class II | Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1480-2019 Class II | Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1479-2019 Class II | Drill, cannulated, 2x95mm, AO, Item Number ST502015623An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1478-2019 Class II | Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1477-2019 Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1476-2019 Class II | Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1475-2019 Class II | Drill, cannulated, 4x150mm, AO, Item Number ST502015403An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1474-2019 Class II | Drill, cannulated, 4x120mm, AO, Item Number ST502015402An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1473-2019 Class II | Drill, 2.7x125mm, AO , Item Number ST502015217An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1472-2019 Class II | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1471-2019 Class II | Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1470-2019 Class II | Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1469-2019 Class II | Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1468-2019 Class II | Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1452-2019 Class II | Drill, contra-angle, 1.5x85mm, Item Number 502015706An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1451-2019 Class II | Drill, 3.2x145mm, AO, Item Number 502015650An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1450-2019 Class II | Drill, cannulated, 4x90mm, round shaft, Item Number 502015640An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1449-2019 Class II | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1448-2019 Class II | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1447-2019 Class II | V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1446-2019 Class II | Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1445-2019 Class II | V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1444-2019 Class II | Drill, cannulated, 3x90mm, AO, Item Number 502015631An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1443-2019 Class II | Drill, cannulated, 3x90mm, round shaft, Item Number 502015630An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1442-2019 Class II | Drill, cannulated, 2.8x150mm, AO, Item Number 502015629An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1441-2019 Class II | Drill, cannulated, 2.8x120mm, AO, Item Number 502015628An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1440-2019 Class II | Drill, cannulated, 2x95mm, AO, Item Number 502015623An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1439-2019 Class II | Drill, cannulated, 2.5x95mm, AO, Item Number 502015621An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1438-2019 Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1437-2019 Class II | Drill, cannulated, 2x95mm, round shaft, Item Number 502015619An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1436-2019 Class II | Drill, cannulated, 4x150mm, AO, Item Number 502015403An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1435-2019 Class II | Drill, cannulated, 4x120mm, AO, Item Number 502015402An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |