Keystone Dental Inc: Medical Device Recall in 2013 - (Recall #: Z-0973-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Product Classification:

Class II

Date Initiated: March 11, 2013

Date Posted: March 27, 2013

Recall Number: Z-0973-2013

Event ID: 64633

Reason for Recall:

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Status: Terminated

Product Quantity: 120 units

Code Information:

Lot Number: 12857

Distribution Pattern:

Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.

Voluntary or Mandated:

Voluntary: Firm initiated