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Terminated

Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.

FDA Recall Z-1221-2007 · Posted 2007-09-18

Recalling FirmBiomet 3i
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-08-03
Date Terminated2009-09-11
Product Quantity240 (120 each model / lot)

Reason for Recall

The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

Firm Action

International customers were contacted first by e-mail , then by fax letter 08/03/2007.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITEImplant Innovations, Inc. · 2007-04-24K9502043I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)Implant Innovations, Inc. · 1995-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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