Biomet 3i Dental Implant recall: Labeling Error
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Why was Biomet 3i Dental Implant recalled?
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.
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?
Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
- Product
- Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 51
- Distribution
- Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)