Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3),
FDA device recall Z-1217-2014 · posted 2014-03-18 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 242
- Distribution
- USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
- Date initiated
- 2014-01-06
- Date posted
- 2014-03-18
- Date terminated
- 2014-08-04
- Location
- Gainesville, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH GIBRALT SPINAL SYSTEM (K110197) | Exactech, Inc. | 2011-07-15 |