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Vertessa Lite Strips 4x22cm

Caldera Medical, Inc. · Model CAL-VLY422ST · UDI-DI 00890594000391

OTO Prescription
1
510(k) clearances
4,780
Adverse events (24 deaths)
1
Recalls
20
Facilities

Description

Vertessa® Lite Strips, 4x22cm polypropylene mesh for sacrocolpopexy

Recalls

DateFirmReason
2013-04-12Coloplast Manufacturing US, LLCColoplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

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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.