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OSUNG MND
OSUNG MND Co., Ltd. · Model MICSA08 · UDI-DI 08800075621276
10
510(k) clearances
5,883
Adverse events (2 deaths)
19
Recalls
302
Facilities
Description
A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. |
| 2019-03-19 | Stryker Instruments Div. of Stryker Corporation | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. |
| 2018-07-27 | Synvasive Technology Inc | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. |
| 2015-12-08 | Synvasive Technology Inc | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. |
| 2015-10-14 | Stryker Sustainability Solutions | It was reported that packaging was not properly sealed. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2013-04-02 | Synvasive Technology Inc | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a recipro |
| 2012-05-21 | Stryker Endoscopy | Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of For |
| 2011-06-13 | Stryker Instruments Division of Stryker Corporation | Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle. |
| 2010-10-20 | Terumo Cardiovascular Systems Corporation | The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide |
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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.