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Trilogy®

Zimmer, Inc. · Model 6141-46-28 · UDI-DI 00889024638136

MLRLPH Prescription
2
510(k) clearances
5,242
Adverse events (4 deaths)
46
Recalls
24
Facilities

Recalls

DateFirmReason
2018-07-26Steris CorporationThere is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterila
2017-09-28Steris CorporationCorrection to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
2017-01-09Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during
2015-07-17Advanced Sterilization ProductsAdvanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypro
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi
2013-11-21Steris CorporationCustomers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solu
2013-11-11Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyuretha

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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.