Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Reported: August 21, 2013 Initiated: May 10, 2013 #Z-1960-2013
Product Description
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Reason for Recall
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.
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 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.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L). Recalled by Biomet 3i, LLC. Units affected: 51.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1960-2013.
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