Skip to content

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive… recallZ-0117-2015 · Straumann USA, LLC · initiated Sep 19, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Straumann USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

FDA root cause category: Packaging process control

What the company is doing

Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.

Recall details

Recall number
Z-0117-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 19, 2014
Posted by the FDA
Oct 23, 2014
Recalling firm
Straumann USA, LLC
Quantity
6 units
Product code
DZE
FDA submissions
K140878
Distribution
US Distribution in states of: FL and MA.

Product description

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.

Code information (models, lots, serial numbers)

Lot number: GY030 Exp. 2019-04

Other devices under the same FDA submission

39 devices cleared under K140878 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page