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KeriFlex

Keri Medical SA · Model 210-P20004 · UDI-DI 07640181160686

KYJ Prescription
1
510(k) clearances
492
Adverse events
4
Recalls
19
Facilities

Recalls

DateFirmReason
2025-06-18Osteotec LimitedThere is the potential that the silicone implant may contain foreign material
2019-11-04Integra Lifesciences Sales LlcSilicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
2016-11-08Wright Medical Technology, Inc.The firm discovered a lack of adequate documentation confirming sterility on certain products.
2016-11-08Wright Medical Technology, Inc.The firm discovered a lack of adequate documentation confirming sterility on certain products.

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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.