Medical Device Recall: Z-0040-2018

FDA Recalls dataset · Firm: Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446 · Status: Terminated

Recall Action Class: N/A Date Initiated: 2015-11-05 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0040-2018.

Recall Res Number
Z-0040-2018
FEI Number
3008455034
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2015-11-05
Date Posted
N/A
Date Terminated
2018-07-19
Product Code
LRZ
Event Number
78181
Product Quantity
120 units
Product Description Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Reason for Recall Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Action Details Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070.
Distribution Pattern US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
Code Information / Serial Numbers Lot numbers: 10923, 109231, 11476, 11993, WT20150630A

Related Establishments / Registrations

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