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Endo-Chisel, with handle
Joimax GmbH · Model TEC273715 · UDI-DI 04250337119630
10
510(k) clearances
71
Adverse events (1 deaths)
3
Recalls
219
Facilities
Description
Bone Ablating Instruments (Curettes, Dissectors and Chisels) are hand-held manual surgical instruments, used to dissect or scrape/chisel tissue from a bony or soft tissue structure during minimally invasive endoscopic spinal surgery. It is typically a long, rigid instrument constructed of medical-grade stainless steel whose distal end has one or more sharp edges in order to fulfill the intended function described above. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2013-11-05 | Zimmer, Inc. | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged pr |
| 2011-07-15 | X Spine Systems Inc | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque i |
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