Reported Mar 26, 2014 · Terminated
Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3),…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- 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 followingDDD (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
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published 05-000-20-3514Lot Number #35917001. size 3.5mm x 14mm 05-000-20-3520Lot Number 35917002 and 40023002. size 3.5mm x 20mm 05-000-20-3526Lot Number 35917003. size 3.5mm x 26mm 05-000-20-4014Lot Number 35917004. size 4.0mm x 14mm 05-000-20-4020Lot Number 35917005. size 4.0mm x 20mm 05-000-20-4026Lot Number 35917006. size 4.0mm x 26mm 05-000-20-3526Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm 05-000-20-3530Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm 05-000-20-4026Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm 05-000-20-4030Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm — Lot Number 35917011. - Amount recalled
- 242
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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