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CoreLink Disposable Ring Clip 26mm

Lumitex, Inc. · Model 6460-032 · UDI-DI 00812432022730

FDG Prescription
2
510(k) clearances
89
Adverse events
2
Recalls
75
Facilities

Recalls

DateFirmReason
2009-07-01Lumitex IncAdhesive 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
2008-10-24Biomet Microfixation, Inc.Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

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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.