Z-0957-2017 Class II Terminated
FDA device recall Z-0957-2017 was initiated by Straumann Manufacturing, Inc. on November 23, 2016 and is designated Class II. Reason for recall: Drills cannot be inserted into handpiece due to tolerance specification not met The recall status is terminated (terminated August 29, 2019). Affected quantity: 165 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- November 23, 2016
- Termination Date
- August 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units
Product Description
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 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
Reason for Recall
Drills cannot be inserted into handpiece due to tolerance specification not met
Distribution Pattern
Nationwide Distribution
Code Information
Lot Number: LV463, MG783, MH027