EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
FDA Recall Z-0029-05 · Posted 2004-10-21
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Recalling FirmImplant Innovations, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2004-10-04
Date Terminated2005-02-07
Product Quantity216 units
Reason for Recall
The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
Firm Action
Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.
Root Cause
Other
Distribution Pattern
Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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