Penta-Morphic
Rmo, Inc. · Model E01531 · UDI-DI 00885797020437
DZC
Prescription
10
510(k) clearances
328
Adverse events
4
Recalls
171
Facilities
Description
BIOLAST DMPL PENTA OVOID 16X22
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-11-04 | Ormco/Sybronendo | Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. |
| 2013-12-13 | Highland Metals, Inc. | Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark |
| 2013-12-13 | Highland Metals, Inc. | Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark |
| 2011-03-15 | Ormco Corporation | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. |
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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.