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Terminated

Calix P PEEK Lumbar System, PLIF Trial

FDA Recall Z-0125-2017 · Posted None

Recalling FirmX Spine Systems Inc
Recall StatusTerminated
Product CodeMAX
Date Initiated2016-05-17
Date Terminated2019-04-04
Product Quantity1504 units

Reason for Recall

The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.

Firm Action

Consignees will be notified via email and courier and will be instructed to return the affected product. Upon receipt of the recalled trays, the trials and rasps will be removed from the tray and quarantined for evenutal destruction.

Root Cause

Component design/selection

Distribution Pattern

Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131350CALIX LUMBAR SPINAL IMPLANT SYSTEMX-Spine Systems, Inc. · 2013-10-23

Official Source

View FDA Recall →

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

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