Atlas FDA

Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043

FDA device recall Z-0840-06 · posted 2006-05-04 · Terminated

Recall details

Recalling firm
Straumann Manufacturing Inc.
Reason for recall
The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
Action taken
Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.
Root cause
Other
Status
Terminated
Product code
DZE
Quantity affected
103 units
Distribution
Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA
Date initiated
2006-03-30
Date posted
2006-05-04
Date terminated
2006-06-14
Location
Andover, MA

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Related 510(k) clearances

RecordFirmDate
TITANIUM HEALING CAPS (K960634)The Straumann Co.1996-06-18