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Fiber Optic Cable
Lumitex, Inc. · Model 005776 · UDI-DI 00812432020569
2
510(k) clearances
89
Adverse events
2
Recalls
76
Facilities
Description
The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-07-01 | Lumitex Inc | Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifi |
| 2008-10-24 | Biomet Microfixation, Inc. | Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. |
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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.