Nobel Biocare Usa Llc: Medical Device Recall in 2016 - (Recall #: Z-2375-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.

Product Classification:

Class II

Date Initiated: July 20, 2016

Date Posted: August 17, 2016

Recall Number: Z-2375-2016

Event ID: 74782

Reason for Recall:

Incorrect drill protocol in the Instructions for Use (IFU)

Status: Terminated

Product Quantity: 231 kits

Code Information:

Article 38072-all lots

Distribution Pattern:

Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated