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IMEDICOM SAW BLADE

IMEDICOM CO., LTD. · Model BSO-210C · UDI-DI 08809288938041

GFA

510(k) clearances

5,861

Adverse events (2 deaths)

Recalls

302

Facilities

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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Data 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.