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Terminated

EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.

FDA Recall Z-0922-2007 · Posted 2007-06-14

Recalling FirmBiomet 3i
Recall StatusTerminated
Product CodeDZE
Date Initiated2006-10-16
Date Terminated2008-12-30

Reason for Recall

Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.

Firm Action

Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.

Root Cause

Other

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934126ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTSImplant Innovations, Inc. · 1994-04-25

Official Source

View FDA Recall →

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

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