FDA Device recall Z-0405-2021

SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoraci…

FDA Device
Class III
terminated
Published 2020-11-11

On 2020-11-11 the FDA classified a Class III recall of SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoraci… by Synthes Usa Products, citing incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device".

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0405-2021
Classification	Class III
Status	terminated
Initiated	2020-09-21
Published	2020-11-11
Last updated	2026-09-13 11:55 UTC
Company	Synthes Usa Products
Distribution	n/a

Product

SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - 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.

Reason

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

Identifiers

code_info	Lot Numbers: 16L1245 16L7630 42P1145 42P4281 M22

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.