Z-1217-2014Class II

Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic...

Name: Z-1217-2014 Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic...
Creator: Exactech, Inc.
Published: 2014-01-06
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2014-01-06 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of 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... on 2014-01-06. FDA classified it as Class II and gives the reason as "The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1217-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-03-18
Terminated: 2014-08-04
Recalling firm: Exactech, Inc.
Product: 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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 242
Distribution: USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
Product codes and lots: size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001. size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002. size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003. size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004. size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005. size 4.0mm x 20mm, Catalog #05-000-20-4020, Lot Number 35917006. size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1217-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1217-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18

Product code MNI

K110197Class IIExactech Gibralt Spinal SystemExactech, Inc. / cleared 2011-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)