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.
Recall
- Recall Number
- Z-0320-2011
- Event Number
- 52231
- Firm
- Straumann Manufacturing Inc.
- FEI Number
- 1000121052
- Product Code
- NDP
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 4, 2009
- Posted
- November 4, 2010
- Terminated
- February 20, 2012
- Address
- 60 Minuteman Rd, Andover, MA, 01810
Description
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.
Incorrect Inner diameter of the T-sleeve
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.
Worldwide Distribution - Canada
3 units