Home › Medicon eG. Chirurgiemechaniker-Genossenschaft › Medicon Epiplating System
Medicon Epiplating System
Medicon eG. Chirurgiemechaniker-Genossenschaft · Model 68.80.42 · UDI-DI 04046826123703
HXX
Prescription
4
510(k) clearances
23,256
Adverse events (4 deaths)
32
Recalls
465
Facilities
Description
screwdriver for covering screws and healing cap
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.