Spine Smith Holdings, LLC: Medical Device Recall in 2013 - (Recall #: Z-2258-2013)

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:

VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

Product Classification:

Class II

Date Initiated: July 31, 2013

Date Posted: September 25, 2013

Recall Number: Z-2258-2013

Event ID: 65999

Reason for Recall:

The product has the potential to be laser marked as a Medium when it actually is a Small.

Status: Terminated

Product Quantity: 32

Code Information:

Part Number: 0301-1410, Lot 53AR

Distribution Pattern:

Distributed in FL.

Voluntary or Mandated:

Voluntary: Firm initiated