UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
FDA Recall Z-2760-2015 · Posted 2015-09-11
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Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2015-07-29
Date Terminated2016-05-16
Product Quantity61 pieces
Reason for Recall
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
Firm Action
Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454
Root Cause
Process control
Distribution Pattern
Worldwide Distribution including Italy and Uruguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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