Straumann Manufacturing, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0958-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
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
Product Classification:
Class II
Date Initiated: November 23, 2016
Date Posted: January 18, 2017
Recall Number: Z-0958-2017
Event ID: 75983
Reason for Recall:
Drills cannot be inserted into handpiece due to tolerance specification not met
Status: Terminated
Product Quantity: 120 units
Code Information:
Lot Number: LV455
Distribution Pattern:
Nationwide Distribution
Voluntary or Mandated:
Voluntary: Firm initiated