Z-1411-2015 Class II Terminated
FDA device recall Z-1411-2015 was initiated by Biomet 3I, LLC on Nov 7, 2014 and is designated Class II. Reason for recall: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. The recall status is terminated (terminated May 22, 2015). Affected quantity: 620 implants in total.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2015
- Initiation Date
- Nov 7, 2014
- Termination Date
- May 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 620 implants in total
Product Description
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Reason for Recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
Code Information
Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1411-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026