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Terminated

SPI EASY Abutment. Endosseous dental implant abutment.

FDA Recall Z-1086-2007 · Posted 2007-07-24

Recalling FirmThommen Medical, AG
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-04-19
Date Terminated2008-05-12
Product Quantity84

Reason for Recall

The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.

Firm Action

Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023645SPI EASY DENTAL IMPLANT ABUTMENTThommen Medical AG · 2002-11-13

Official Source

View FDA Recall →

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

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