Recall Z-1960-2013— Biomet 3i, LLC

Name: FDA recall Z-1960-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-10

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2013-05-10, terminated 2014-08-13. It names one FDA 510(k) clearance: K122300. Product: Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L). Reason: 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..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Terminated: 2014-08-13
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K122300 — T3 DENTAL IMPLANTBiomet 3i·cleared 2013-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.