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Polyform™
BOSTON SCIENTIFIC CORPORATION · Model M0068402590 · UDI-DI 08714729845256
OTO
Prescription
10
510(k) clearances
4,773
Adverse events (24 deaths)
1
Recalls
20
Facilities
Description
Synthetic Mesh
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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Get your free API keyRead the docsData 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.