OSSEOTITE Certain 2 Implant recall
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Why was OSSEOTITE Certain 2 Implant recalled?
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018
- Product
- OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 620 implants in total
- Distribution
- 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.
- Recall date
- April 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)