Genesys Orthopedic Systems, LLC: Medical Device Recall in 2013 - (Recall #: Z-0921-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 20, 2013

Date Posted: March 20, 2013

Recall Number: Z-0921-2013

Event ID: 64421

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.

Status: Terminated

Product Quantity: 9 cervical screws

Code Information:

Part Number: GCSF37512 and Lot Number: 0243

Distribution Pattern:

USA Nationwide Distribution including the states of: CA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated