Skip to the content

FDA Medical Device Recalls (openFDA)

Biomet 3i, LLC: 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.

Recall number
Z-2760-2015
Recalling firm
Biomet 3i, 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.
Status
Terminated
Initiated
2015-07-29
Posted
2015-09-11
Terminated
2016-05-16
Reason
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
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
61 pieces
Distribution
Worldwide Distribution including Italy and Uruguay.
Lot, serial or model codes
Model # MUCC1C LOT # 1186054
510(k) numbers
["K072642"]
PMA numbers
not on file
Product code
NHA
Firm FEI
1038806
Firm city
Palm Beach Gardens
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Search this register