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Integra® Jarit®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 505205 · UDI-DI 10381780158554

HDC Prescription
10
510(k) clearances
47
Adverse events (1 deaths)
8
Recalls
22
Facilities

Description

Integra® Jarit® BRAUN TENACULUM FORCEPS

Recalls

DateFirmReason
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2011-07-29GYN Disposables IncLack of sterility assurance.

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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.