Medical Device Recall: Z-0029-05

FDA Recalls dataset · Firm: Implant Innovations, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-10-04 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-05.

Recall Res Number
Z-0029-05
Recalling Firm / Manufacturer
Implant Innovations, Inc.
FEI Number
1038806
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-10-04
Date Posted
2004-10-21
Date Terminated
2005-02-07
Product Code
DZE
Event Number
30203
Product Quantity
216 units
Product Description EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
Reason for Recall The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
Action Details 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.
Distribution Pattern Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
Code Information / Serial Numbers Product Code: THA54 Lot No. 249229

Related Establishments / Registrations

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