Recall Z-1217-2014 ยท MNI Orthosis, Spinal Pedicle Fixation
Exactech, Inc.
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
| Date | Mar 18, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 242 |
| Distribution | USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110197 | EXACTECH GIBRALT SPINAL SYSTEM Exactech, Inc., Jul 15, 2011 |