Z-1037-2008

Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover...

Name: Z-1037-2008 Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover...
Creator: Straumann Usa, Llc
Published: 2008-01-10
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2008-01-10 / Terminated / root cause: labeling and UDI

FDA source

Straumann Usa, Llc began a recall of Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810 on 2008-01-10. The reason FDA records is "Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1037-2008
Status: Terminated
Initiated: 2008-01-10
Posted: 2008-04-30
Terminated: 2009-11-06
Recalling firm: Straumann USA, LLC
Product: Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
Product code: EGG Attachment, Precision, All
Reason for recall: Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.
Quantity in commerce: 26 units
Distribution: Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
Product codes and lots: Lot Number: G8677

Product code EGG

K071585Class IIP.004 Healing Abutments and Closure ScrewsStraumann USA / cleared 2007-07-11

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)