Gibralt Spine System Polyaxial Screw Intended to promote fusion of… — Class II medical device recall Z-1217-2014
Terminated recall by Exactech, Inc., reported 2014-03-26, distributed in FL, IL, MO, NJ, NY, OR, PA. The products have been identified to contain springs which have been manufactured with type-304 stainless stee
| Recall number | Z-1217-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2014-01-06 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-08-04 |
| Distributed | FL, IL, MO, NJ, NY, OR, PA |
| Quantity | 242 |
| Lot numbers | 1/4, 35917001, 35917002, 35917003, 35917004, 35917005, 35917006, 35917007, 35917008, 35917009, 35917010, 35917011, 40023002 |
| Model numbers | 05-000-20-3510, 05-000-20-3514, 05-000-20-3520, 05-000-20-3526, 05-000-20-3530, 05-000-20-4014, 05-000-20-4020, 05-000-20-4026, 05-000-20-4030 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1217-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.