Z-0320-2011

Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide...

Name: Z-0320-2011 Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide...
Creator: Straumann Manufacturing Inc.
Published: 2009-06-04
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2009-06-04 / Terminated / root cause: manufacturing process

FDA source

Straumann Manufacturing Inc. began a recall of Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide to prepare a site for placement of a dental... on 2009-06-04. The reason FDA records is "Incorrect Inner diameter of the T-sleeve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0320-2011
Status: Terminated
Initiated: 2009-06-04
Posted: 2010-11-04
Terminated: 2012-02-20
Recalling firm: Straumann USA, LLC
Product: Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Incorrect Inner diameter of the T-sleeve
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Strauman USA LLC notified the consignee by telephone on June 4, 2009, and sent an Urgent Device Recall letter dated, June 8, 2009 as a follow-up. The letter described the product, the problem, and the action to be taken by the customer. The customer was asked to return any affected product, in the prepaid preprinted mailer pouch as soon as possible to: T-sleeve Recall, Straumann USA, LLC 60 Minuteman Road Andover, MA, 01810 Customers were asked to sign and indicate on the Recall Acknowledgement Form if they would like a replacement product or a credit to their account for the product returned and fax the form to (978) 747-0023. For any questions regarding this recall call (978) 747-2575.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution - Canada
Product codes and lots: Lot# R9483

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)