Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
FDA Recall Z-1217-2014 · Posted 2014-03-18
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2014-01-06
Date Terminated2014-08-04
Product Quantity242
Reason for Recall
The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.
Firm Action
Exactech sent an "URGENT PRODUCT RECALL NOTICE" dated January 6, 2014, to all affected customers. The letter identified the product and action needed to taken by the customers. Customers were instructed to: 1) Immediately cease distribution. 2) Extend the information to accounts in possession of the product. 3) Verify if they have any of the subject Gibralt Screws from the specified lots. 4) Complete and fax back the attached form. 5) Return affected products. For further questions, please call ( 352) 327-4847.
Root Cause
Mixed-up of materials/components
Distribution Pattern
USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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