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Terminated

XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant)

FDA Recall Z-0232-2007 · Posted 2006-12-01

Recalling FirmDentsply Friadent Ceramed
Recall StatusTerminated
Product CodeDZE
Date Initiated2006-11-17
Date Terminated2007-04-30
Product Quantity1680 units

Reason for Recall

Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

Firm Action

Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.

Root Cause

Other

Distribution Pattern

Worldwide-USA and one Canadian consignee.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032750MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLEFriandent GmbH · 2003-10-02

Official Source

View FDA Recall →

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

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