Z-0921-2013Class II

3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System

Name: Z-0921-2013 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System
Creator: Genesys Orthopedic Systems, LLC
Published: 2013-02-20
License: https://open.fda.gov/license/

Genesys Spine / initiated 2013-02-20 / Terminated / root cause: manufacturing process

FDA source

Genesys Orthopedic Systems, LLC began a recall of 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to... on 2013-02-20. FDA classified it as Class II and gives the reason as "Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0921-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-03-08
Terminated: 2013-09-09
Recalling firm: Genesys Spine
Product: 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
Quantity in commerce: 9 cervical screws
Distribution: USA Nationwide Distribution including the states of: CA and TX.
Product codes and lots: Part Number: GCSF37512 and Lot Number: 0243

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0921-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code KWQ

K111132Class IIGenesys Spine Anterior Cervical Plate SystemGenesys Spine / cleared 2011-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)