GSS Pedicle Screw System
GS Medical Co., Ltd. · Model GS0101-4525 · UDI-DI 08806378342016
Description
"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System. The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion."
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-12 | XTANT MEDICAL INC | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. |
| 2016-11-22 | Amendia, Inc | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
| 2015-04-07 | X Spine Systems Inc | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. |
| 2015-03-11 | X Spine Systems Inc | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. |
| 2013-01-11 | Synthes USA HQ, Inc. | Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of |
| 2012-09-25 | Alphatec Spine, Inc. | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated P |
| 2009-07-01 | Stryker Spine | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod |
| 2009-04-02 | EBI, L.P. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
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