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Integra® Jarit®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 205321 · UDI-DI 10381780455035

FFO Prescription
5
510(k) clearances
86
Adverse events
3
Recalls
152
Facilities

Description

Integra® Jarit® Balfour Center Blade, 10-3/4", 3-5/8" Wide, 1-3/4" Deep, for REF#'s 205-315 and 205-316, Standard

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2015-11-25Abeon Medical CorporationThe firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
2015-11-25Abeon Medical CorporationThe firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

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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.