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Terminated

Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410

FDA Recall Z-0128-2008 · Posted 2008-01-17

Recalling FirmBiomet 3i
Recall StatusTerminated
Product CodeNHA
Date Initiated2007-10-08
Date Terminated2008-07-10
Product Quantity114

Reason for Recall

Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.

Firm Action

Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA, Italy, France, Spain and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060291PREFORMANCE TEMPORARY CYLINDERImplant Innovations, Inc. · 2006-02-27

Official Source

View FDA Recall →

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

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