Home › TOBY ORTHOPAEDICS › T10 Driver, w/ Quick Connect
T10 Driver, w/ Quick Connect
TOBY ORTHOPAEDICS · Model NA · UDI-DI 00816101017904
4
510(k) clearances
23,256
Adverse events (4 deaths)
32
Recalls
465
Facilities
Description
Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-25 | Synthes (USA) Products LLC | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay |
| 2021-10-25 | Aesculap Implant Systems LLC | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. |
| 2021-04-15 | Flower Orthopedics Corporation | Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages |
| 2019-05-28 | Zimmer Biomet, Inc. | There is a potential for weak seals of the sterile packaging. |
| 2019-03-14 | Trilliant Surgical, LLC | A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to r |
| 2018-05-04 | Synthes (USA) Products LLC | The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely. |
| 2016-04-27 | Orthofix, Inc | There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque han |
| 2016-04-26 | Greatbatch Medical | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SA |
| 2014-05-15 | Ebi, Llc | The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. |
| 2014-01-03 | Medtronic Sofamor Danek USA Inc | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.