Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
FDA Recall Z-0840-06 · Posted 2006-05-04
Recalling FirmStraumann Manufacturing Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2006-03-30
Date Terminated2006-06-14
Product Quantity103 units
Reason for Recall
The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
Firm Action
Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.
Root Cause
Other
Distribution Pattern
Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA
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.