Straumann Manufacturing Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Straumann Manufacturing Inc.
Lot Codes / Batch Numbers
Lot# R9483
Products Sold
Lot# R9483
Straumann Manufacturing Inc. is recalling Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilli due to Incorrect Inner diameter of the T-sleeve. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Inner diameter of the T-sleeve
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026