Z-0840-06

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

Name: Z-0840-06 Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
Creator: Straumann Manufacturing Inc.
Published: 2006-03-30
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2006-03-30 / Terminated

FDA source

Straumann Manufacturing Inc. began a recall of Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043 on 2006-03-30. The reason FDA records is "The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0840-06
Status: Terminated
Initiated: 2006-03-30
Posted: 2006-05-04
Terminated: 2006-06-14
Recalling firm: Straumann USA, LLC
Product: Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
FDA root cause: Other
Action: Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.
Quantity in commerce: 103 units
Distribution: Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA
Product codes and lots: Lot Number: A3667

Product code DZE

K960634Class IITitanium Healing CapsThe Straumann Co. / cleared 1996-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)