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Straumann Standard Plus Implant 04.8mm Wide Neck recallZ-1351-2012 · Straumann USA, LLC · initiated Mar 12, 2012

Terminated All recalls posted in March 2012

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

Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN

FDA root cause category: Packaging process control

What the company is doing

Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.

Recall details

Recall number
Z-1351-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 12, 2012
Posted by the FDA
Mar 30, 2012
Recalling firm
Straumann USA, LLC
Quantity
346 units
Product code
NDP
FDA submissions
K033922
Distribution
Nationwide Distribution.

Product description

Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. 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 No. CW642

Other devices under the same FDA submission

42 devices cleared under K033922 — 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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