Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
FDA Recall Z-2237-2016 · Posted None
Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-06-22
Date Terminated2016-09-06
Product Quantity53 units total (33 units in US)
Reason for Recall
Incorrect top label on an implant package.
Firm Action
Nobel Biocare sent a customer notification letter dated June 23, 2016 to all affected customers to inform them that Nobel Biocare has detected that the lot#13030677 of Replace Select Tapered TiU NP 3.5 x 11.5 mm (product#36105) carries an incorrect top label. The letter informs the customers that the incorrect top label states "Replace NP 3.5 x 11.5 CC" (ie. Conical Connection). The product, Replace Select Tapered TiU NP 3.5 x 11.5 mm, has a Tri-lobe connection. Customers were instructed to complete the attached Quality Message Acknowledgement form. Customer with questions were instructed to contact customer service at 714-282-4808.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.