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Terminated

Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.

FDA Recall Z-1698-2012 · Posted 2012-06-01

Recalling FirmGenesys Orthopedic Systems, LLC
Recall StatusTerminated
Product CodeMAX
Date Initiated2011-08-24
Date Terminated2012-12-04
Product Quantity4 inserters

Reason for Recall

The inserters have the potential to break.

Firm Action

Genesys Orthopedic Systems, LLC decided to recall the affected product and called their customers on August 24, 2011. The firm removed the inserters from distribution from 8/24-31/2011.

Root Cause

Reprocessing Controls

Distribution Pattern

Nationwide Distribution including Florida and Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103034GENESYS SPINE INTERBODY FUSION SYSTEMGenesys Spine · 2010-12-10

Official Source

View FDA Recall →

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

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