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.
FDA Recall Z-0407-2021 · Posted None
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Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeMQP
Date Initiated2020-09-21
Date Terminated2022-12-30
Product Quantity5 units
Reason for Recall
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM
instead of 'specially controlled medical device"
Firm Action
Synthes GMBH is reporting Recall of SYNMESH CAGE SYSTEM Japan-Specific Country Label Issue . The Japan affiliate will be administering the recall per their local regulations, the week of September 21, 2020. Affiliate will notify Japanese sales representatives. Japanese sales representatives will hand-deliver notices to affected hospitals / surgeons.
The Japan affiliate is responsible for managing the rework process. Returned devices will be reworked with correct Japan-specific labels and revised lots
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
International distribution the country of Japan Only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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