Atlas FDA

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

FDA device recall Z-0926-05 · posted 2005-06-23 · Terminated

Recall details

Recalling firm
BioHorizons Implant Systems Inc
Reason for recall
The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
Action taken
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
Status
Terminated
Product code
NDP
Quantity affected
23 units
Distribution
PA, TX, MI, VA and Russia
Date initiated
2005-06-03
Date posted
2005-06-23
Date terminated
2005-08-11
Location
Birmingham, AL

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