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Terminated

Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.

FDA Recall Z-1876-2008 · Posted 2008-09-16

Recalling FirmStraumann Manufacturing Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2008-05-28
Date Terminated2009-11-06
Product Quantity129 units

Reason for Recall

Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.

Firm Action

On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Class III Recall - Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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