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Terminated

Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.

FDA Recall Z-0811-2007 · Posted 2007-05-16

Recalling FirmBiomet 3i
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-04-25
Date Terminated2008-11-18
Product Quantity362 units

Reason for Recall

The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.

Firm Action

Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.

Root Cause

Other

Distribution Pattern

Distributed worldwide, including USA, Spain and the Netherlands.

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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