Greatbatch Medical Offset Cup Impactor

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Class 1 Device Recall Greatbatch, Offset Cup Impactor

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149161

Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint …

FDA: Class I recall of Standard Offset Cup Impactor

https://www.ormanager.com/briefs/fda-class-i-recall-of-standard-offset-cup-impactor-by-greatbatch-medical/

The Food and Drug Administration (FDA) on December 20 classified the recall by Greatbatch Medical (Frisco, Texas) of its Standard Offset Cup Impactor with a POM …

Class 1 Device Recall Offset Cup Impactor - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=125387

The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup …

Greatbatch Medical Standard Offset Cup Impactor …

https://www.igj.nl/binaries/igj/documenten/waarschuwingen/2016/07/28/greatbatch-medical-ref-3004976965-07_28_2016-003-c---standard-offset-cup-impactor-with-pom-c-handle/IT1029865+Greatbatch+Medical+3004976965-07_28_2016-003-C+-+Standard+Offset+Cup+Impactor.pdf

Greatbatch has determined that when a Standard Offset Cup Impactor with POM-C handle is sterilized when placed in an instrument case or tray per the current Instructions …

International Medical Devices Database

https://medicaldevices.icij.org/events/usa-greatbatch-offset-cup-impactor

Impactor - Product Code HWA Reason On december 17, 2015, greatbatch discovered that the standard offset cup impactor with a pom-c handle grip failed sterility testing when …

Greatbatch Medical Issues Voluntary Field Corrective …

https://www.globenewswire.com/news-release/2016/11/16/890480/0/en/Greatbatch-Medical-Issues-Voluntary-Field-Corrective-Action-for-Standard-Offset-Cup-Impactor.html

Nov 16, 2016

Greatbatch Medical Recalls Standard Offset …

https://www.medicaldesignandoutsourcing.com/greatbatch-medical-recalls-standard-offset-cup-impactor-used-for-hip-joint-replacement-due-to-inadequate-sterilization/

Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization. December 28, 2016 By The U.S. …

Standard Offset Cup Impactor Attorney Miami | Goldberg …

https://www.goldbergandrosen.com/practice-areas/medical-devices/standard-offset-cup-impactor/

The U.S. Food and Drug Administration (FDA) announced a recall of Greatbatch Medical’s Standard Offset Cup Impactor, a surgical tool used in hip joint replacement surgery. …

Greatbatch Medical Recalls Hip Instrument for Failing …

https://www.searcylaw.com/greatbatch-medical-recalls-hip-device/

Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls in the joint area after …

Greatbatch Medical Standard Offset Cup Impactor - LWW

https://journals.lww.com/biomedicalsafetystandards/Citation/2017/02150/Greatbatch_Medical_Standard_Offset_Cup_Impactor.3.aspx

Greatbatch Medical Standard Offset Cup Impactor : Biomedical Safety & Standards Previous Abstract Next Abstract Full Text Access for Subscribers: Individual …

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