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Corn.Treph.

KATENA PRODUCTS, INC. · Model 08-17016 · UDI-DI 00841668121016

HRH Prescription
10
510(k) clearances
23
Adverse events
1
Recalls
121
Facilities

Description

LASEK 9.5mm Well & 9.0mm Epi Trephine

Recalls

DateFirmReason
2013-05-03Surgical 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.

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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.