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Terminated

Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.

FDA Recall Z-0412-2013 · Posted 2012-11-21

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2012-08-28
Date Terminated2015-06-11
Product Quantity17 units

Reason for Recall

Inspan Compressors may break at weld causing a loss of compression

Firm Action

Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093438PARADIGM INTERSPINOUS FUSION PLATEParadigm Spine, LLC · 2010-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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