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Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm… recallZ-0174-2015 · Straumann USA, LLC · initiated Sep 24, 2014

Class II Terminated All recalls posted in November 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

Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

FDA root cause category: Packaging process control

What the company is doing

Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.

Recall details

Recall number
Z-0174-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 24, 2014
Posted by the FDA
Nov 6, 2014
Recalling firm
Straumann USA, LLC
Quantity
111 units
Product code
DZE
FDA submissions
K121131
Distribution
US Nationwide Distribution

Product description

Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: 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. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

Code information (models, lots, serial numbers)

Lot number: GY256

Other devices under the same FDA submission

14 devices cleared under K121131 — 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

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