RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
FDA Recall Z-0975-05 · Posted 2005-07-07
Recalling FirmStraumann Manufacturing Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2005-06-06
Date Terminated2005-11-03
Product Quantity23
Reason for Recall
Basal screw is too short to adequately hold the dental abutment in the implant
Firm Action
Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.
Root Cause
Other
Distribution Pattern
AZ, CA, DE, FL, NY, OH, OK, TX
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.