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JOBST Opaque

BSN MEDICAL, INC. · Model 7769122 · UDI-DI 04042809525366

DWL
10
510(k) clearances
70
Adverse events (3 deaths)
4
Recalls
105
Facilities

Description

OPAQUE 30-40 MM HG THIGH HIGH WOVEN SILICONE CLOSED TOE LARGE-PETITE NATURAL 1 DA EN FI FR IT NO PT

Recalls

DateFirmReason
2014-03-19Zimmer, Inc.During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19Zimmer, Inc.During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19Zimmer, Inc.During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19Zimmer, Inc.During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

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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.