—#125540

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.

FDA product code: MNI — Orthosis, Spinal Pedicle Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110197
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.

Timeline

Recall initiated: 2014-01-06
Posted by FDA: 2014-03-18
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125540. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.