Recall Z-1411-2015— Biomet 3i, LLC

Name: FDA recall Z-1411-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-07

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2014-11-07, terminated 2015-05-22. It names one FDA 510(k) clearance: K130949. Product: OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.. Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Terminated: 2015-05-22
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K130949 — CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSBiomet 3i·cleared 2013-07-30

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

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

Reason for recall

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

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