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

FDA device recall Z-0320-2011 · posted 2010-11-04 · Terminated

Recall details

Recalling firm

Straumann Manufacturing Inc.

Reason for recall

Incorrect Inner diameter of the T-sleeve

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

NDP

Quantity affected

3 units

Distribution

Worldwide Distribution - Canada

Date initiated

2009-06-04

Date posted

2010-11-04

Date terminated

2012-02-20

Location

Andover, MA