Z-1828-2012 Class II Terminated
FDA device recall Z-1828-2012 was initiated by Biomet 3I, LLC on Nov 4, 2011 and is designated Class II. Reason for recall: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. The recall status is terminated (terminated Jun 25, 2012). Affected quantity: 219 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 27, 2012
- Initiation Date
- Nov 4, 2011
- Termination Date
- Jun 25, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 219 units in total
Product Description
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Reason for Recall
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Distribution Pattern
Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
Code Information
Lot #2010111529
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1828-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026