SpineFrontier, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1482-2013)

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:

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

Product Classification:

Class II

Date Initiated: May 10, 2008

Date Posted: June 12, 2013

Recall Number: Z-1482-2013

Event ID: 64991

Reason for Recall:

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

Status: Terminated

Product Quantity: 10

Code Information:

Lot number: 20856

Distribution Pattern:

Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.

Voluntary or Mandated:

Voluntary: Firm initiated