Synthes (USA) Products LLC: Medical Device Recall in 2020 - (Recall #: Z-0417-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Product Classification:

Class III

Date Initiated: September 21, 2020

Date Posted: November 11, 2020

Recall Number: Z-0417-2021

Event ID: 86545

Reason for Recall:

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

Status: Terminated

Product Quantity: 18 units

Code Information:

Lot Numbers: 13L2504 M22

Distribution Pattern:

International distribution the country of Japan Only.

Voluntary or Mandated:

Voluntary: Firm initiated