3i Osseotite Certain Dental Implants recall
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Why was 3i Osseotite Certain Dental Implants recalled?
Product was incorrectly packaged.
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?
Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
- Product
- 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 92 units
- Distribution
- US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
- Recall date
- September 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)