Recall Z-0957-2017— Straumann Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by Straumann Manufacturing, Inc., initiated 2016-11-23, terminated 2019-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Drills cannot be inserted into handpiece due to tolerance specification not met.
- Recalling firm
- Straumann Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-23
- Terminated
- 2019-08-29
- Firm location
- Andover, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.