Full OSSEOTITE Parallel Walled Certain Implant recall
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic…
Why was Full OSSEOTITE Parallel Walled Certain Implant recalled?
Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
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 Number IFOA411, Lot # 2011111333, 2011111333-S1
- Product
- Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic…
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 76 devices
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
- Recall date
- November 28, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)