Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
FDA Recall Z-0801-2007 · Posted 2007-05-11
Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-04-18
Date Terminated2007-08-11
Product Quantity34 units
Reason for Recall
Dental implant system is missing ball attachment system.
Firm Action
Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.
Root Cause
Other
Distribution Pattern
Worldwide distribution ---- USA and country of Italy
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.