Gibralt Spine System Polyaxial Screw Intended to recall
Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is…
Why was Gibralt Spine System Polyaxial Screw Intended to recalled?
The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Exactech, Inc.
- Quantity
- 242
- Distribution
- USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
- Recall date
- March 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)