Z-2760-2015Class II

UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a...

Name: Z-2760-2015 UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a...
Creator: Biomet 3i, LLC
Published: 2015-07-29
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2015-07-29 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous... on 2015-07-29. FDA classified it as Class II and gives the reason as "MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2760-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Posted: 2015-09-11
Terminated: 2016-05-16
Recalling firm: ZimVie US Corp LLC
Product: 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.
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 61 pieces
Distribution: Worldwide Distribution including Italy and Uruguay.
Product codes and lots: Model # MUCC1C LOT # 1186054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2760-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2760-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-11

Product code NHA

K072642Class IIBiomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. / cleared 2007-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)