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Terminated

Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. 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

FDA Recall Z-0958-2017 · Posted None

Recalling FirmStraumann Manufacturing, Inc.
Recall StatusTerminated
Product CodeNDP
Date Initiated2016-11-23
Date Terminated2019-08-29
Product Quantity120 units

Reason for Recall

Drills cannot be inserted into handpiece due to tolerance specification not met

Firm Action

Straumann sent an Urgent Field Safety Notice to all affected customers via UPS on November 23, 2016 for next day delivery. Customers were requested to check inventory for the listed article and lot numbers and return all unused, packaged parts. Replacement drills will be sent upon receipt. Complete the Confirmation Form and fax the form to the number listed on the form. For questions regarding this recall call 800-448-8168.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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