FDA Device recall Z-0407-2021
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, tho…
- FDA Device
- Class III
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class III recall of SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, tho… 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-0407-2021 |
| 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¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - 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: 10L8490 17P3848 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-0407-2021%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.