Recall Z-0279-2018— Zimmer Dental Inc

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-10-11, terminated 2019-03-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.. Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant..

Recalling firm

Zimmer Dental Inc

Classification

Class II

Status

Terminated

Initiated

2017-10-11

Terminated

2019-03-13

Firm location

Carlsbad, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.