SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1933-2013)

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:

Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.

Product Classification:

Class II

Date Initiated: June 21, 2013

Date Posted: August 14, 2013

Recall Number: Z-1933-2013

Event ID: 65653

Reason for Recall:

Difficulty removing screws from the Invue caddies.

Status: Terminated

Product Quantity: 13

Code Information:

Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R

Distribution Pattern:

Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.

Voluntary or Mandated:

Voluntary: Firm initiated