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Restorelle

Coloplast A/S · Model 501330 · UDI-DI 05708932483285

OTO Prescription

510(k) clearances

4,778

Adverse events (24 deaths)

Recalls

Facilities

Description

Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - XL

Recalls

Date	Firm	Reason
2013-04-12	Coloplast Manufacturing US, LLC	Coloplast 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.