Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
FDA device recall Z-1961-2013 · posted 2013-08-13 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- 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.
- Action taken
- The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 33
- Distribution
- Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
- Date initiated
- 2013-05-10
- Date posted
- 2013-08-13
- Date terminated
- 2014-08-13
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T3 DENTAL IMPLANT (K122300) | Biomet 3i | 2013-01-30 |