Z-0858-2017 Class II Terminated
FDA device recall Z-0858-2017 was initiated by Biomet 3I, LLC on Sep 14, 2016 and is designated Class II. Reason for recall: A limited number of product pouches may not have been sealed during packaging. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 270.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Sep 14, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270
Product Description
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Reason for Recall
A limited number of product pouches may not have been sealed during packaging.
Distribution Pattern
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Code Information
Part #LPCPTC2 Lot #'s 2016011174, 2016011175 and 2016011178
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0858-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026