Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

FDA Recall Z-1960-2013 · Posted 2013-08-13

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2013-05-10
Date Terminated2014-08-13
Product Quantity51

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.

Firm Action

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

Distribution Pattern

Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122300T3 DENTAL IMPLANTBiomet 3i · 2013-01-30

Official Source

View FDA Recall →

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

↑