Z-1960-2013 Class II Terminated
FDA device recall Z-1960-2013 was initiated by Biomet 3I, LLC on May 10, 2013 and is designated Class II. Reason for recall: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 51.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2013
- Initiation Date
- May 10, 2013
- Termination Date
- Aug 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51
Product Description
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Reason for Recall
A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Distribution Pattern
Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Code Information
Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1960-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026