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Terminated

The Maestor System 225-312, Profile Abutment for Cement, 5mm

FDA Recall Z-0926-05 · Posted 2005-06-23

Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeNDP
Date Initiated2005-06-03
Date Terminated2005-08-11
Product Quantity23 units

Reason for Recall

The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.

Firm Action

The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.

Root Cause

Other

Distribution Pattern

PA, TX, MI, VA and Russia

Official Source

View FDA Recall →

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

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