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SIENTRA Oval Carving Block Implant

Sientra, Inc. · Model 3232-030U · UDI-DI 00812790024971

MIB Prescription
1
510(k) clearances
184
Adverse events
3
Recalls
11
Facilities

Description

Oval Carving Block Implant, 13 cc

Recalls

DateFirmReason
2025-09-26DSAART LLCDue to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
2025-09-26DSAART LLCDue to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
2025-09-26DSAART LLCDue to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

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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.