Recall Z-2258-2013— Spine Smith Holdings, LLC

Name: FDA recall Z-2258-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Class II · Terminated

Class II FDA medical device recall by Spine Smith Holdings, LLC, initiated 2013-07-31, terminated 2014-03-18. It names one FDA 510(k) clearance: K102090. Product: 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.. Reason: The product has the potential to be laser marked as a Medium when it actually is a Small..

Recalling firm: Spine Smith Holdings, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Terminated: 2014-03-18
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K102090 — SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMSpine Smith Partners L.P.·cleared 2010-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.