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Gutta Percha 04-60
Meta Biomed Co., Ltd. · Model 0477 · UDI-DI 08806387804772
EKM
Prescription
10
510(k) clearances
128
Adverse events
3
Recalls
106
Facilities
Description
Gutta Percha Points and Bars 04 taper #60, 60 Points, P71
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-08 | Ormco/Sybronendo | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as S |
| 2010-09-09 | Ormco Corporation | The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled. |
| 2009-10-27 | Sybronendo | The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability requ |
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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.